SHIMADZU MobileDaRt Evolution — Class II medical device recall Z-1039-2019
Terminated recall by Shimadzu Medical Systems Usa Com, reported 2019-03-27, distributed nationwide. In these units, the brake is usually released by gripping the drive handle and applied by letting go of the ha
| Recall number | Z-1039-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems Usa Com, Torrance, CA, United States |
| Recall initiated | 2019-01-14 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2023-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 93 units |
| UPC / GTIN / UDI-DI | 04540217059621 |
Product
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).
Reason for recall
In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.
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-1039-2019. 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.