Medical device recalls Moderate risk

Stryker Communications recalls Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000

Recall date
October 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1602-2020
FDA classification
Class II
Brand / firm
Stryker Communications
Sold / distributed
US: Nationwide OUS: Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000

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