FDA recall record · openFDA
Philips North America Llc
221 FDA recalls on record (2023–2026) — 221 device. 221 still ongoing.
4
Class I (most serious)
217
Class II
0
Class III
221
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Patient support table floor plate may be incorrectly installed. 41
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smo 30
Potential issue where the IntelliVue monitors did not alarm. 22
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiVi 18
Potential safety issue where a patient may be harmed while preparing for or during a scan. 13
Recalls
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy Class I 2024-06-05 SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy Class I 2024-06-05 SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achiev Class I 2024-06-05 Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst Class I 2023-11-17 Brilliance iCT; Product Code (REF): 728306; Class II 2026-01-07 Spectral CT; Product Code (REF): 728333; Class II 2026-01-07 IQon Spectral CT; Product Code (REF): 728332; Class II 2026-01-07 DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. Class II 2026-05-01 Spectral CT 7500 on Rails; Product Code (REF): 728334; Class II 2026-01-07 IntelliVue MP90. Product Number: M8010A. Class II 2025-10-31 IntelliVue MP30. Product Number: M8002A. Class II 2025-10-31 Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub Class II 2025-04-07 IntelliVue Patient Monitor MX800. Product Number: 865240. Class II 2025-10-31 Spectral CT. Computed tomography X-ray system. Class II 2025-05-29 Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143; Class II 2025-05-13 IntelliVue Patient Monitor MX400. Model Number: 866060 Class II 2025-01-15 Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, in Class II 2025-02-25 IntelliVue Patient Monitor MX450. Model Number: 866062 Class II 2025-01-15 IntelliVue Patient Monitor MX700. Product Number: 865241. Class II 2025-10-31 CT 5300; Software Version Number: 4.5, 5.0, 5.1; Class II 2025-10-29 IntelliVue Patient Monitor MX550. Model Number: 866066 Class II 2025-01-15 IntelliVue Patient Monitor MX500. Product Number: 866064. Class II 2025-10-31 Product Name: Ingenia 3.0T CX; Model Number: 781271; Class II 2025-05-13 IntelliVue Patient Monitor MX850. Product Number: 866470. Class II 2025-10-31 Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, Class II 2025-02-25 Product Name: Ingenia 1.5T CX; Model Number: 781262; Class II 2025-05-13 Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; Class II 2025-05-13 IntelliVue MP2. Product Number: M8102A. Class II 2025-10-31 Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, i Class II 2025-02-25 Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306. Class II 2025-08-13 Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System. Class II 2025-04-01 Incisive CT; Software Version Number: 4.5, 5.0, 5.1; Class II 2025-10-29 Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332. Class II 2025-08-13 IntelliVue Patient Monitor MX500. Model Number: 866064 Class II 2025-01-15 Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Onco Class II 2025-08-13 IntelliVue MP50. Product Number: M8004A. Class II 2025-10-31 Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325. Class II 2025-08-13 Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136; Class II 2025-05-13 IntelliVue MP80. Product Number: M8008A. Class II 2025-10-31 Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103; Class II 2025-05-13 IntelliVue Patient Monitor MX100. Product Number: 867033. Class II 2025-10-31 IntelliVue MP40. Product Number: M8003A. Class II 2025-10-31 Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307. Class II 2025-08-13 Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. Class II 2025-03-10 Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Sl Class II 2025-08-13 Product Name: Ingenia 1.5T S; Model Number: 781347; Class II 2025-05-13 Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 Class II 2025-05-13 Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138; Class II 2025-05-13 IntelliVue Multi Measurement Server X2. Product Number: M3002A. Class II 2025-10-31 Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT Class II 2025-08-13 Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137; Class II 2025-05-13 Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144; Class II 2025-05-13 IntelliVue MP60. Product Number: M8005A. Class II 2025-10-31 Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139; Class II 2025-05-13 IntelliVue MP5. Product Number: M8105A. Class II 2025-10-31 IntelliVue MP20. Product Number: M8001A. Class II 2025-10-31 Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326 Class II 2025-08-13 Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; Class II 2025-05-13 IntelliVue Patient Monitor MX600. Product Number: 865242. Class II 2025-10-31 Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113; Class II 2025-05-13 IntelliVue Patient Monitor MX400. Product Number: 866060. Class II 2025-10-31 Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. Class II 2025-03-10 IntelliVue Multi-Measurement Module X3. Product Number: 867030. Class II 2025-10-31 Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324. Class II 2025-08-13 Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146 Class II 2025-05-13 Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. Class II 2025-12-12 IntelliVue Patient Monitor MX550. Product Number: 866066. Class II 2025-10-31 IntelliVue Patient Monitor MX750. Product Number: 866471. Class II 2025-10-31 IntelliBridge EC10 Module. Model Number: 865115 Class II 2025-01-15 IntelliVue Patient Monitor MX450. Product Number: 866062. Class II 2025-10-31 Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311. Class II 2025-08-13 Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; Class II 2025-05-13 Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140; Class II 2025-05-13 Product Name: Upgrade to MR 7700; Model Number: 782130; Class II 2025-05-13 IntelliVue MP70. Product Number: M8007A. Class II 2025-10-31 Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for Class II 2024-04-22 Ingenia 1.5T S, Magnetic Resonance System. Class II 2024-03-12 Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. Class II 2024-04-19 Achieva 1.5T, Magnetic Resonance System. Class II 2024-03-12 Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177 Class II 2024-05-03 Intera 1.5T Omni/Stellar, Magnetic Resonance System. Class II 2024-03-12 Achieva 3.0T, Magnetic Resonance System. Class II 2024-03-12 HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Pro Class II 2024-05-03 MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic Class II 2024-05-03 GYROSCAN T5-NT, Magnetic Resonance System. Class II 2024-03-12 Intera 1.5T, Magnetic Resonance System. Class II 2024-03-12 Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359 Class II 2024-05-03 Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev Class II 2024-05-03 dS Breast 16ch 1.5T Class II 2024-11-04 SmartPath to dStream for 3.0T Model Number (REF): 782145 Class II 2024-05-03 Intera 1.5T Achieva Nova, Magnetic Resonance System. Class II 2024-03-12 Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143 Class II 2024-05-03 Intera 1.5T Achieva IT Nova, Magnetic Resonance System. Class II 2024-03-12 Mammotrak Interventional Coil 3.0T Class II 2024-11-04 Intera 1.0T Omni/Stellar, Magnetic Resonance System. Class II 2024-03-12 GYROSCAN ACS-NT, Magnetic Resonance System. Class II 2024-03-12 Achieva XR, Magnetic Resonance System. Class II 2024-03-12 Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of t Class II 2024-09-03 Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr Class II 2024-09-03 Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 Class II 2024-11-20 Mammotrak Diagnostic Coil 1.5T Class II 2024-11-04 Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. Class II 2024-03-12 Ingenia 1.5T CX, Magnetic Resonance System. Class II 2024-03-12 Ingenia Elition S, Magnetic Resonance System. Class II 2024-03-12 Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra o Class II 2024-09-03 HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Produc Class II 2024-05-03 Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti Class II 2024-05-03 Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or sp Class II 2024-09-03 Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. Class II 2024-03-12 MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Mode Class II 2024-05-03 Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated fo Class II 2024-04-22 MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Class II 2024-05-03 Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. Class II 2024-11-16 The Oncology Essentials Package of the Spectral CT imaging system. Class II 2024-03-29 IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicate Class II 2024-06-28 dS Breast 7ch 3.0T Class II 2024-11-04 HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Produc Class II 2024-05-03 Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti Class II 2024-05-03 Ingenia Elition X, Magnetic Resonance System. Class II 2024-03-12 Enterprise 1.5T, Magnetic Resonance System. Class II 2024-03-12 Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. M Class II 2024-05-03 Achieva 1.5T Initial system Model Number (REF): 781178 Class II 2024-05-03 IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicate Class II 2024-06-28 MR 7700, Magnetic Resonance System. Class II 2024-03-12 MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Class II 2024-05-03 GYROSCAN T5, Magnetic Resonance System. Class II 2024-03-12 Intera Achieva 1.5T Pulsar, Magnetic Resonance System. Class II 2024-03-12 Achieva 3.0TX for PET, Magnetic Resonance System. Class II 2024-03-12 SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im Class II 2024-09-03 Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev Class II 2024-05-03 ST SENSE Breast Dx Coil Class II 2024-11-04 Intera CV, Magnetic Resonance System. Class II 2024-03-12 Achieva 1.5T Conversion, Magnetic Resonance System. Class II 2024-03-12 DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD Class II 2024-02-15 Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra Class II 2024-09-03 Intera 1.5T R11, Magnetic Resonance System. Class II 2024-03-12 SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images an Class II 2024-09-03 SENSE Breast Coil Class II 2024-11-04 Achieva 1.5T Initial, Magnetic Resonance System. Class II 2024-03-12 Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr Class II 2024-09-03 Intera 1.0T Power/Pulsar, Magnetic Resonance System. Class II 2024-03-12 Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device M Class II 2024-05-03 Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of th Class II 2024-09-03 SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images a Class II 2024-09-03 Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Class II 2024-05-03 Evolution Upgrade 3.0T, Magnetic Resonance System. Class II 2024-03-12 Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Class II 2024-05-03 IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicat Class II 2024-06-28 IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicate Class II 2024-06-28 Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra Class II 2024-09-03 SENSE Breast Coil 3.0T 7ch Class II 2024-11-04 Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporati Class II 2024-03-22 SmartPath to dStream for 1.5T, Magnetic Resonance System. Class II 2024-03-12 Achieva 3.0T for PET, Magnetic Resonance System. Class II 2024-03-12 Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic d Class II 2024-05-03 MR 5300, Magnetic Resonance System. Class II 2024-03-12 dS Breast 7ch 1.5T Class II 2024-11-04 Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Class II 2024-05-03 Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271 Class II 2024-05-03 MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the in Class II 2024-09-03 SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a dia Class II 2024-05-03 Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti Class II 2024-05-03 Ingenia Ambition X, Magnetic Resonance System. Class II 2024-03-12 Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devic Class II 2024-05-03 Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315 Class II 2024-05-03 SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use a Class II 2024-05-03 Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728 Class II 2024-04-15 Intera 1.5T Power/Pulsar, Magnetic Resonance System. Class II 2024-03-12 SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a d Class II 2024-05-03 Intera 0.5T Standard, Magnetic Resonance System. Class II 2024-03-12 MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the in Class II 2024-09-03 SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. Class II 2024-03-12 dS Breast 16ch 3.0T Class II 2024-11-04 ST SENSE Breast Coil Class II 2024-11-04 Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728 Class II 2024-04-15 Ingenia 1.5T, Magnetic Resonance System. Class II 2024-03-12 Mammotrak Interventional Coil 1.5T Class II 2024-11-04 Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal he Class II 2024-05-22 GYROSCAN T10-NT, Magnetic Resonance System. Class II 2024-03-12 Intera 3.0T Quasar Dual, Magnetic Resonance System. Class II 2024-03-12 Ingenia 1.5T S Model Number (REF): 781347 Class II 2024-05-03 Ingenia 3.0T, Magnetic Resonance System. Class II 2024-03-12 Ingenia Ambition S, Magnetic Resonance System. Class II 2024-03-12 AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Mode Class II 2024-05-03 Mammotrak Diagnostic Coil 3.0T Class II 2024-11-04 Achieva 3.0T TX for PET Model Number (REF): 781479 Class II 2024-05-03 Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devi Class II 2024-05-03 Achieva TX Interventional Coil 3.0T Class II 2024-11-04 Intera 1.5T Master/Nova, Magnetic Resonance System. Class II 2024-03-12 Ingenia 3.0T CX, Magnetic Resonance System. Class II 2024-03-12 DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images. Class II 2023-09-21 Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Pr Class II 2023-08-17 CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system Class II 2023-09-21 Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiati Class II 2023-10-09 IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affecte Class II 2023-06-14 DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images. Class II 2023-09-21 DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images. Class II 2023-09-21 Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncolo Class II 2023-10-09 DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images. Class II 2023-09-21 EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultan Class II 2023-08-31 Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201 Class II 2023-03-09 ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system Class II 2023-09-21 DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204 Class II 2023-03-09 SmartPath to dStream for 1.5T Class II 2023-10-23 DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images. Class II 2023-09-21 DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images Class II 2023-09-21 EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images. Class II 2023-09-21 Ingenia 1.5T CX Class II 2023-10-23 Achieva 1.5T Class II 2023-10-23 EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359 Class II 2023-03-06 EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380 Class II 2023-03-06 Achieva 1.5T Initial System Class II 2023-10-23 DigitalDiagnost C90, Model No. 712034 and 712035 Class II 2023-05-19 Achieva 1.5T Conversion Class II 2023-10-23 EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) si Class II 2023-08-31 Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 Class II 2023-03-17 DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images. Class II 2023-09-21 Intera 1.5T Power/Pulsar Class II 2023-10-23 Intera 1.5T Class II 2023-10-23 Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. Class II 2023-11-30 Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed fo Class II 2023-10-09
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.