MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM… — Class II medical device recall Z-1642-2014
Terminated recall by Fujifilm Medical System USA, Inc., reported 2014-05-28, distributed in KY, TX. The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 1
| Recall number | Z-1642-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical System USA, Inc., Stamford, CT, United States |
| Recall initiated | 2012-06-29 |
| Classified | 2014-05-21 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2018-06-01 |
| Distributed | KY, TX |
| Countries outside the US | CN |
| Quantity | 14 |
| Reason classes | labeling |
Product
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Reason for recall
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
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-1642-2014. 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.