Severe FDA (Devices)·Z-2248-2017·Announced 2017-06-14

Stryker Recalls Berchtold Chromophare F300 Exam Lights Due to Mounting Defect

Stryker Communications is recalling 57 Berchtold Chromophare F300 exam lights because a tolerance issue may cause the equipment to fall, posing a risk of serious injury.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the defect may cause the equipment to fall, resulting in serious injury. Per the rubric, significant injury reports or risks of serious injury in medical devices warrant a Severe (4) classification.

Plain-English summary

Stryker Communications is recalling 57 units of the Berchtold Chromophare F300 Exam Light. These medical lights are used for local illumination of patients' bodies to aid in the diagnosis and treatment of illnesses, injuries, and disabilities. The affected units were distributed in the US and Canada.

The recall is due to a potential tolerance issue with the adapter assembly. This defect may prevent the snap ring from seating correctly, resulting in insufficient mount force. If the mount force is insufficient, the equipment may fall, which could result in serious injury.

Healthcare facilities and consumers should check their serial numbers against the list provided in the official recall notice to determine if their units are affected. No specific instructions for remediation are provided in the source text, but users should contact the manufacturer for guidance.

The recalled product

Product: 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
Manufacturer: Stryker Communications
Category: Medical Device — Examination Lights
Hazard: falling-object
serious-injury
Affected units: 57

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Numbers: 7735170-X68377
7735170-X68397
7735170-X14846
7735170-X15688
7735170-X14492
7735170-X14495
7735170-X14497
7735170-X14501
7735170-X14502
7735170-X14504
7735170-X14506
7735170-X14507
7735170-X14508
7735170-X14510
7735170-X68383
7735170-X68384
7735170-X68385
7735170-X68386
7735170-X68393
7735170-X68394

Distribution

Distribution scope not specified by the agency.

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