Smart CR Digital Computed Radiography System — Class II medical device recall Z-1599-2016
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2016-05-11, distributed nationwide. Reports of failure of the device's power supply.
| Recall number | Z-1599-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Stamford, CT, United States |
| Recall initiated | 2016-04-01 |
| Classified | 2016-05-03 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2018-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 2,062 devices |
| Model numbers | CR-IR346RU |
Product
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Reason for recall
Reports of failure of the device's power supply.
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-1599-2016. 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.