CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
Maquet G8 / G8E OR Light Systems recalled by Getinge Usa Sales
Getinge Usa Sales is recalling Maquet G8 / G8E OR Light Systems, distributed nationwide in the US. The recall was initiated on 8 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0769-2024
- FDA event ID
- 93567
- Recalling firm
- Getinge Usa Sales, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Nov 2023
- FDA classified
- 18 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Nov 2023 | Recall initiated by company | |
| 18 Jan 2024 | Classified by FDA | +71 days |
| 24 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential for a light system to fall in the operating room.
Product as listed by the FDA
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
Where it was distributed
US Nationwide. Global Distribution.
Questions about this recall
Is Maquet G8 / G8E OR Light Systems recalled?
Yes. Getinge Usa Sales recalled Maquet G8 / G8E OR Light Systems on 8 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0769-2024.
Why was it recalled?
A potential for a light system to fall in the operating room.
Which lots are affected?
All systems affected
Where was it sold?
US Nationwide. Global Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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