Getinge Usa Sales Inc: 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

Recall number

Z-0758-2024

Recalling firm

Getinge Usa Sales Inc

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

Status

Open, Classified

Initiated

2023-11-08

Posted

2024-01-19

Terminated

not on file

Reason

A potential for a light system to fall in the operating room.

Root cause

Equipment maintenance

Action

An URGENT MEDICAL DEVICE CORRECTION letter dated 11/8/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have been identified as having purchased at least one model of one of these product ranges. Please identify your affected units using the referenced devices on page 1 and follow the instructions below. Please distribute this notice and forward the link below to access manuals to anyone within your organization who may need to use the manuals, and especially to your service or service provider who performs your maintenance. Light system fixing and other replacements: Regarding: - the fixing of the light systems: suspensions fixing screws, adapter fixing screws, bushing fixing screws - the brake screws - the safety segments - the batteries, a dedicated instruction to illustrate and facilitate understanding of what to replace and what to order for replacement has been issued. The instruction is available on a dedicated space on the web portal https://www.getinge.com/int/campaigns/maintenance-and-service-on-or-light-system/, and provided upon request by emailing MSA808092.sw@getinge.com Should you have questions or require additional information, please do not hesitate to contact Maquet SAS/Getinge or your local representative. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 7) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to or-lights2023.qrc@getinge.com or by faxing the form to (866) 350-0897. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Actions to be taken by Maquet SAS / Getinge: As the majority of customers may not have regular contact with Getinge services or authorized Getinge representatives and therefore may not be aware of current maintenance recommendations, Maquet SAS/Getinge is providin

Quantity

236793 units in total

Distribution

US Nationwide. Global Distribution.

Lot, serial or model codes

All systems affected UDI-DI: 03700712400798 03700712400804 03700712400811 03700712400828 03700712400835 03700712400842 03700712400859 03700712400866 03700712400873 03700712400880 03700712400897 03700712400903

510(k) numbers

["K130513"]

PMA numbers

not on file

Product code

FTD

Firm FEI

3013876692

Firm city

Wayne

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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