Carestream DRX-1 System Battery --- Made in U — Class II medical device recall Z-2202-2012
Terminated recall by Carestream Health, Inc., reported 2012-08-22, distributed nationwide. Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery
| Recall number | Z-2202-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2012-06-12 |
| Classified | 2012-08-13 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2016-05-25 |
| Distributed | Nationwide (US) |
| Quantity | 9,971 units |
| Reason classes | device malfunction |
Product
Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
Reason for recall
Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.
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-2202-2012. 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.