Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, ROL FOR VLT400SF STP - ARDROL309000A, ROL FOR VLT400SF STP - ARDROL309000C, ROL FOR VLT600SF STP - ARDROL309002A, ROL FOR VLT600SF STP - ARDROL309002C, VCS40 ROL - ARDROL309024A, VCS40 ROL - ARDROL309024C, VCS40 ROL - ARDROL309028A, VCS40 ROL - ARDROL309028C, VCS60 ROL - ARDROL309025A, VCS60 ROL - ARDROL309025C, VCS60 ROL - ARDROL309029A, VCS60 ROL - ARDROL309029C, VST40 - ARDROL309016A, VST40 - ARDROL309016C, VST40 - ARDROL309017A, VST40 - ARDROL309017C, VST40 - ARDROL309020A, VST40 - ARDROL309020C, VST40 - ARDROL309022A, VST40 - ARDROL309022C, VST60 - ARDROL309018A, VST60 - ARDROL309018C, VST60 - ARDROL309019A, VST60 - ARDROL309019C, VST60 - ARDROL309021A, VST60 - ARDROL309021C, VST60 - ARDROL309023A, VST60 - ARDROL309023C, VCS40DF - ARDVCS209001A, VCS40DF - ARDVCS209001C, VCS40DF - ARDVCS209010A, VCS40DF - ARDVCS209012A, VCS40DF - ARDVCS209021A, VCS40SF - ARDVCS209000A, VCS40SF - ARDVCS209000C, VCS40SF - ARDVCS209011A, VCS40SF 08 - ARDVCS209046A, VCS44DF - ARDVCS209005A, VCS44DF - ARDVCS209005C, VCS44DF - ARDVCS209016A, VCS44SF - ARDVCS209004A, VCS44SF - ARDVCS209004C, VCS44SF - ARDVCS209015A, VCS44SFDF - ARD2VCS00040A, VCS60DF - ARDVCS209003A, VCS60DF - ARDVCS209003C, VCS60DF - ARDVCS209014A, VCS60DF - ARDVCS209022A, VCS60DF 11 - ARDVCS209047A, VCS60SF - ARDVCS209002A, VCS60SF - ARDVCS209002C, VCS60SF - ARDVCS209013A, VCS64DF - ARDVCS209007A, VCS64DF - ARDVCS209007C, VCS64DF - ARDVCS209018A, VCS64SF - ARDVCS209006A, VCS64SF - ARDVCS209006C, VCS64SF - ARDVCS209017A, VCS64SFDF - ARD2VCS00010A, VCS64SFDF 1011 - ARDVCS209048A, VCS66DF - ARDVCS209009A, VCS66DF - ARDVCS209009C, VCS66DF - ARDVCS209020A, VCS66SF - ARDVCS209008A, VCS66SF - ARDVCS209008C, VCS66SF - ARDVCS209019A, VCSII40DF SB08 - ARDVCS209023A, VCSII40DF SB11 - ARDVCS209024A, VCSII40SF SB11 - ARDVCS209025A, VCSII44DF SB0810 - ARDVCS209026A, VCSII44SF SB1011 - ARDVCS209027A, VCSII60DF SB08 - ARDVCS209028A, VCSII60SF SB11 - ARDVCS209029A, VCSII64DF SB0810 - ARDVCS209030A, VCSII64SF SB1011 - ARDVCS209031A, VCSII66DF SB0810 - ARDVCS209032A, VCSII66SF SB1011 - ARDVCS209033A, VCSII40DF TK SB08 - ARDVCS209034A, VCSII40DF TK SB11 - ARDVCS209035A, VCSII40SF TK SB11 - ARDVCS209036A, VCSII44DF TK SB0810 - ARDVCS209037A, VCSII44SF TK SB1011 - ARDVCS209038A, VCSII60DF TK SB08 - ARDVCS209039A, VCSII60SF TK SB11 - ARDVCS209040A, VCSII64DF TK SB0810 - ARDVCS209041A, VCSII64SF TK SB1011 - ARDVCS209042A, VCSII66DF TK SB0810 - ARDVCS209043A, VCSII66SF TK SB1011 - ARDVCS209044A, VCS40DF SAT 12 - ARD2VCS00070A, VCSII40SF SB08 - ARDVCS209049A, VCSII64SFDF SB1011 - ARDVCS209050A, SAT VLT400D - ARD2SAT00080C, SAT VLT400D - ARD2SAT00100C, SAT VLT400DF - ARD2SAT00080A, SAT VLT400DF - ARD2SAT00100A, SAT VLT400S - ARD2SAT00030C, SAT VLT400S - ARD2SAT00040C, SAT VLT400SF - ARD2SAT00040A, SAT VLT40DF - ARD268800130A, SAT VLT40DF - ARD268800130C, SAT VLT40SF - ARD268800120A, SAT VLT40SF - ARD268800120C, SAT VLT60DF - ARD2SAT00170A, SAT VLT60DF - ARD2SAT00170C, SAT VLT60SF - ARD2SAT00180C, SAT VST40DF - ARDSAT209018A, SAT VST40DF - ARDSAT209019A, SAT VST40DF - ARDSAT209022A, SAT VST40DF - ARDSAT209023A, SAT VST40SF - ARDSAT209010A, SAT VST40SF - ARDSAT209011A, SAT VST40SF - ARDSAT209014A, SAT VST40SF - ARDSAT209015A, SAT VST60DF - ARDSAT209034A, SAT VST60DF - ARDSAT209035A, SAT VST60DF - ARDSAT209038A, SAT VST60DF - ARDSAT209039A, SAT VST60SF - ARDSAT209026A, SAT VST60SF - ARDSAT209027A, SAT VST60SF - ARDSAT209030A, SAT VST60SF - ARDSAT209031A, STANDOP 40DF SINGLE - ARDSTP229005A, STANDOP 40SF SINGLE - ARDSTP229000A, STANDOP 44DF DOUBLE - ARDSTP229007A, STANDOP 44SF DOUBLE - ARDSTP229002A, STANDOP 60DF SINGLE - ARDSTP229006A, STANDOP 60SF SINGLE - ARDSTP229001A, STANDOP 64DF DOUBLE - ARDSTP229008A, STANDOP 64SF DOUBLE - ARDS
Why it was recalled
A potential for a light system to fall in the operating room.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
All systems affected UDI-DI: 03700712400798 03700712400804 03700712400811 03700712400828 03700712400835 03700712400842 03700712400859 03700712400866 03700712400873 03700712400880 03700712400897 03700712400903
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide. Global Distribution.
Recall record
- Recalling firm
- Getinge Usa Sales Inc
- Product type
- Devices
- Recall number
- Z-0758-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Wayne, NJ
- Recall initiated
- 2023-11-08
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0758-2024 · Source: openFDA enforcement.