FDA Device recall Z-0556-2021
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiograph…
- FDA Device
- Class II
- ongoing
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiograph… by Shimadzu Medical Systems, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0556-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-18 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shimadzu Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Affected Serial Numbers: 0161K35901, 0161K46901, 0161K58202, 0161K56001, 0161K55702, 0161K55301, 0161K55202, 01…Affected Serial Numbers: 0161K35901, 0161K46901, 0161K58202, 0161K56001, 0161K55702, 0161K55301, 0161K55202, 0161K47102, 0161K46802, 0161K46301, 0161K36501, 0161K36301, 0161K35702, 0161K36202, 40AAE701B001, 0161K49301, 0161K48601, 0161K48501, 0161K36402, 0161K35602, 0161K35202, 0161K56502 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0556-2021%22
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