Shimadzu Corporation — Class II medical device recall Z-1369-2013
Terminated recall by Shimadzu Medical Systems, reported 2013-06-12, distributed nationwide. The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturin
| Recall number | Z-1369-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2013-03-18 |
| Classified | 2013-06-03 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 200 units |
| Serial numbers | 0162S65709, 0162S65805, 0162S65808, 0162S65809, 0162S65810, 0162S65901, 0162S66001, 0162S66003, 0162S66004, 0162S66005, 0162S66008, 0162S66009, 0162S66010, 0162S66201, 0162S66202, 0162S66205, 0162S66206, 0162S66207, 0162S66208, 0162S66302, 0162S66306, 0162S66307, 0162S66308, 0162S66309, 0162S66402 and 71 more |
Product
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
Reason for recall
The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.
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-1369-2013. 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.