CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report
Berchtold Chromophare F300 Exam Light Chromophare recalled
Stryker Communications is recalling Berchtold Chromophare F300 Exam Light Chromophare examination lights are medical lights. The recall was initiated on 21 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2248-2017
- FDA event ID
- 77261
- Recalling firm
- Stryker Communications, Flower Mound, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Apr 2017
- FDA classified
- 5 Jun 2017
- Reported
- 14 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Apr 2017 | Recall initiated by company | |
| 5 Jun 2017 | Classified by FDA | +45 days |
| 14 Jun 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US and Canada
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - US and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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