Drug recall
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize…
FDA recall event 85999 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 85999 |
|---|---|
| Recall numbers | Z-2755-2020, Z-2756-2020, Z-2757-2020, Z-2758-2020 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image., SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image., SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image., SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system… |
| Initiation date | Jan 8, 2020 |
| Report date | Aug 12, 2020 |
| Termination date | Jun 21, 2022 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
At a glance
- 1–9 Products in this recall
- None 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: