medical Class II Updated 2019-09-18

Stryker Communications recalls Berchtold Chromophare F628 Surgical Lights. Product Usage

Recalled Product

Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.


Hazard / Issue

The back cover of the light head was insufficiently assembled and could potentially fall off the light.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial number ranges: 83171-0017818 to 83171-0123938
View official government recall

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