Data Foundry

Medical device recalls 2017

Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights… — Class II medical device recall Z-2248-2017

Terminated recall by Stryker Communications, reported 2017-06-14. The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the sna

Recall numberZ-2248-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Communications, Flower Mound, TX, United States
Recall initiated2017-04-21
Classified2017-06-05
Reported by FDA2017-06-14
Terminated2017-09-20
Countries outside the USCA
Quantity57 units
Serial numbers7735170-X14492, 7735170-X14495, 7735170-X14497, 7735170-X14501, 7735170-X14502, 7735170-X14504, 7735170-X14506, 7735170-X14507, 7735170-X14508, 7735170-X14510, 7735170-X14846, 7735170-X15607, 7735170-X15608, 7735170-X15609, 7735170-X15610, 7735170-X15611, 7735170-X15612, 7735170-X15613, 7735170-X15614, 7735170-X15615, 7735170-X15688, 7735170-X68377, 7735170-X68383, 7735170-X68384, 7735170-X68385 and 9 more

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2248-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.