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Terminated

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

FDA Recall Z-2248-2017 · Posted None

Recalling FirmStryker Communications
Recall StatusTerminated
Product CodeKZF
Date Initiated2017-04-21
Date Terminated2017-09-20
Product Quantity57 units

Reason for Recall

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.

Firm Action

Stryker Communications sent an Urgent Medical Device Recall letter to all affected customers. A Stryker Representative will contact their facility to schedule a service visit. to replace the adapter assembly to resolve the tolerance issue affected units. Customers with questions were instructed to Stryker Technical Support at 800-243-5135 or [email protected]. For questions regarding this recall call 972-834-8656.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - US and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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