Drug recall
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product…
FDA recall event 86846 · Class II · Shimadzu Medical Systems
Key facts
| Event ID | 86846 |
|---|---|
| Recall numbers | Z-0554-2021, Z-0555-2021, Z-0556-2021 |
| Recalling firm | Shimadzu Medical Systems |
| Product type | Devices |
| Products | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and…, 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…, Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 18, 2020 |
| Report date | Dec 16, 2020 |
| City | Torrance |
| State | CA |
| Country | United States |
| FEI number | 1000125362 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: