FDA Medical Device Recalls (openFDA)
Getinge Usa Sales Inc: Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
- Recall number
- Z-0771-2024
- Recalling firm
- Getinge Usa Sales Inc
- Product
- Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSY
- Firm FEI
- 3013876692
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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