Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2248-2017 — Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated

U.S. FDA — Device Enforcement · United States · 2017-04-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2248-2017
Date of alert
2017-04-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Communications
Product category
device
Product type
Devices
Reported risk: The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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