Maquet Volista — Class II medical device recall Z-0758-2024
Ongoing recall by Getinge Usa Sales Inc, reported 2024-01-24, distributed nationwide. A potential for a light system to fall in the operating room.
| Recall number | Z-0758-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2023-11-08 |
| Classified | 2024-01-18 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 236,793 units |
| UPC / GTIN / UDI-DI | 03700712400798, 03700712400804, 03700712400811, 03700712400828, 03700712400835, 03700712400842, 03700712400859, 03700712400866, 03700712400873, 03700712400880, 03700712400897, 03700712400903 |
| Model numbers | 1011, ARD268800120A, ARD268800120C, ARD268800130A, ARD268800130C, ARD2SAT00030C, ARD2SAT00040A, ARD2SAT00040C, ARD2SAT00080A, ARD2SAT00080C, ARD2SAT00100A, ARD2SAT00100C, ARD2SAT00170A, ARD2SAT00170C, ARD2SAT00180C, ARD2VCS00010A, ARD2VCS00040A, ARD2VCS00070A, ARDROL309000A, ARDROL309000C, ARDROL309001A, ARDROL309001C, ARDROL309002A, ARDROL309002C, ARDROL309003A and 157 more |
Product
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
Reason for recall
A potential for a light system to fall in the operating room.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0758-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.