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Recall Observatory FDA recall evidence

Device product

Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C

Z-0769-2024

November 08, 2023

Class II

Product summary

Firm
Getinge Usa Sales Inc
Event
Event 93567
Status
Ongoing
Classification
Class II
Quantity
236793 units in total
Official record key
device-enforcement:Z-0769-2024

Official wording

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

Code information: All systems affected

Distribution pattern: US Nationwide. Global Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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