Reported Jun 14, 2017 · Terminated

Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of…

Stryker Communications

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Communications · 1410 Lakeside Pkwy Ste 100 · Flower Mound, TX · 75028-4026

Is this the product you have?

  • 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
Lot codes and dates
  • 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
    • 7735170-X68395
    • 7735170-X68396
    • 7735170-X68392
    • 7735170-X68400
    • 7735170-X68401
    • 7735170-X15607
    • 7735170-X15608
    • 7735170-X15609
    • 7735170-X15610
    • 7735170-X15611
    • 7735170-X15612
    • 7735170-X15613
    • 7735170-X15614
    • 7735170-X15615
Amount recalled
57 units

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 20, 2017 · Data as of Sep 19, 5:19 PM UTC

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