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Medical Device Recalls: Getinge Maquet SAS OR Light Systems
Medical Device Recalls: Getinge Maquet SAS OR Light Systems
Introduction:
Getinge, a leading manufacturer of OR Light Systems, has issued multiple Class 2 medical device recalls for the below Lighting Systems.
FDA Recall Links:
Z-0757-2024 – Maquet Blueline Series 30/80 OR Light Systems
Z-0758-2024 – Maquet Lucea – Lucea10/40, Lucea50/100 OR Light Systems
Z-0759-2024 – Maquet Prismalix OR Light Systems
Z-0760-2024 – Maquet Hanaulux HLX2000 OR Light Systems
Z-0761-2024 – Maquet Axcel / Axcel + OR Light Systems
Z-0762-2024 – Maquet Orchide OR Light Systems
Z-0763-2024 – Maquet XTen OR Light Systems
Z-0764-2024 – Maquet PowerLED/HLED and PowerLED300 OR Light Systems
Z-0765-2024 – Maquet G8 / G8E OR Light Systems
Z-0766-2024 – Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems
Z-0767-2024 – Maquet Hanaulux HLX3000 OR Light Systems
Z-0768-2024 – Maquet PowerLEDII OR Light System
Z-0769-2024 – Maquet Rolite OR Light Systems
Z-0770-2024 – Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System
Z-0771-2024 – Maquet Equipment OR Light Systems
Recall Scope:
All Models, All Catalog Numbers.
Introduction:
Getinge, a leading manufacturer of OR Light Systems, has issued multiple Class 2 medical device recalls for the below Lighting Systems.
FDA Recall Links:
Z-0757-2024 – Maquet Blueline Series 30/80 OR Light Systems
Z-0758-2024 – Maquet Lucea – Lucea10/40, Lucea50/100 OR Light Systems
Z-0759-2024 – Maquet Prismalix OR Light Systems
Z-0760-2024 – Maquet Hanaulux HLX2000 OR Light Systems
Z-0761-2024 – Maquet Axcel / Axcel + OR Light Systems
Z-0762-2024 – Maquet Orchide OR Light Systems
Z-0763-2024 – Maquet XTen OR Light Systems
Z-0764-2024 – Maquet PowerLED/HLED and PowerLED300 OR Light Systems
Z-0765-2024 – Maquet G8 / G8E OR Light Systems
Z-0766-2024 – Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems
Z-0767-2024 – Maquet Hanaulux HLX3000 OR Light Systems
Z-0768-2024 – Maquet PowerLEDII OR Light System
Z-0769-2024 – Maquet Rolite OR Light Systems
Z-0770-2024 – Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System
Z-0771-2024 – Maquet Equipment OR Light Systems
Recall Scope:
All Models, All Catalog Numbers.
Reason for Recall:
Getinge USA has stated that a potential for the light system to fall in the operating room is the reason for the recall.
Getinge has developed a comprehensive web site to provide additional information per model line per their Field Action Reference MSA-808092 at https://www.getinge.com/int/campaigns/maintenance-and-service-on-or-light-system/ .
FDA’s Determination:
The FDA has identified equipment maintenance as the cause of the recall.
Recall Quantity:
The recall affects 236,793 total units US Nationwide and Worldwide.
Recall Actions:
The following actions are listed in the Recall:
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.
Contact Information:
Please complete and sign the 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.