Drug & Device Safety Atlas

FDA recall record · openFDA

GE Healthcare Finland Oy

19 FDA recalls on record (2023–2025) — 19 device. 19 still ongoing.

9
Class I (most serious)
10
Class II
0
Class III
19
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

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended volta 9
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capabil 5
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart 5

Recalls

TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter Class I 2023-05-19 TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter Class I 2023-05-19 TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter Class I 2023-05-19 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia dete Class I 2023-05-19 TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs Class I 2023-05-19 TruSignal Wrap Sensor, REF TS-W-D; Oximeter Class I 2023-05-19 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter Class I 2023-05-19 TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear Class I 2023-05-19 TruSignal Ear Sensor, REF TS-E-D; Oximeter Class I 2023-05-19 B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-1 Class II 2025-09-26 CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a Class II 2025-09-26 Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Class II 2025-09-26 BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Pa Class II 2025-09-26 Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spa Class II 2025-09-26 CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e Class II 2024-04-05 CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01 Class II 2024-04-05 CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 20786 Class II 2024-04-05 CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001- Class II 2024-04-05 CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, p Class II 2024-04-05

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.

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