Drug recall
CombiDiagnost R90 Software Version R1.0 and R1.1
FDA recall event 88393 · Class II · Philips Medical Systems Gmbh, DMC
Key facts
| Event ID | 88393 |
|---|---|
| Recall numbers | Z-2357-2021 |
| Recalling firm | Philips Medical Systems Gmbh, DMC |
| Product type | Devices |
| Products | CombiDiagnost R90 Software Version R1.0 and R1.1 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This… |
| Initiation date | Jul 22, 2020 |
| Report date | Sep 8, 2021 |
| City | Hamburg |
| Country | Germany |
| FEI number | 3003768251 |
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: