MH-200S — Class II medical device recall Z-0556-2021
Ongoing recall by Shimadzu Medical Systems, reported 2020-12-16, distributed nationwide. The firm has identified a problem with the control software for the celling arm of the X-Ray System . This sof
| Recall number | Z-0556-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2020-11-18 |
| Classified | 2020-12-10 |
| Reported by FDA | 2020-12-16 |
| Distributed | Nationwide (US) |
| Quantity | 22 units |
| Reason classes | software |
| Serial numbers | 0161K35202, 0161K35602, 0161K35702, 0161K35901, 0161K36202, 0161K36301, 0161K36402, 0161K36501, 0161K46301, 0161K46802, 0161K46901, 0161K47102, 0161K48501, 0161K48601, 0161K49301, 0161K55202, 0161K55301, 0161K55702, 0161K56001, 0161K56502, 0161K58202, 40AAE701B001 |
Product
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Reason for recall
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
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-0556-2021. 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.