FDA-Device2020-04-08Class II

Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000

Stryker Communications
Hazard

The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.

Sold states
US: Nationwide OUS: Canada
Affected count
1415 Surgical Lights
Manufactured in
571 Silveron Blvd, N/A, Flower Mound, TX, United States
Products
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1602-2020

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