Shimadzu Digital Radiography X-Ray System — Class II medical device recall Z-1569-2014
Terminated recall by Shimadzu Medical Systems, reported 2014-05-14, distributed nationwide. Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a l
| Recall number | Z-1569-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2014-04-03 |
| Classified | 2014-05-08 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2015-06-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CN, DE, JP, KR, LK, SA, TH, TW, ZA |
| Serial numbers | 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB22004, 3M72BFB2A001, 3M72BFB32001, 3M72BFB32006, 3M72BFB35005, 3M72BFC2A001, 3M72BFC2C001, 3M72BFC33001, 3M72BFC34001 |
| Model numbers | DAR-8000F |
Product
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
Reason for recall
Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
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-1569-2014. 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.