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Recall Observatory FDA recall evidence

Device product

Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.

Z-0771-2024

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-0771-2024

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.