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Recall Observatory FDA recall evidence

Device product

Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD568803951

Z-0762-2024

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-0762-2024

Official wording

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

Code information: All systems affected UDI-DI: 3700712415761 3700712415976 3700712418274 3700712418281 3700712412340

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.