FDA-Device2024-01-24Class II

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

Getinge Usa Sales Inc
Hazard

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

Sold states
US Nationwide. Global Distribution.
Affected count
236793 units in total
Manufactured in
1 Geoffrey Way, N/A, Wayne, NJ, United States
Products
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0769-2024

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