Drug recall
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
FDA recall event 90490 · Class II · Philips Medical Systems DMC GmbH
Key facts
| Event ID | 90490 |
|---|---|
| Recall numbers | Z-1325-2022, Z-1326-2022, Z-1327-2022, Z-1328-2022, Z-1329-2022 |
| Recalling firm | Philips Medical Systems DMC GmbH |
| Product type | Devices |
| Products | DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system, DigitalDiagnost 4 High Performance. radiography and fluoroscopy system, DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system, DigitalDiagnost C90 High Performance. radiography and fluoroscopy system, ProxiDiagnost N90. radiography and fluoroscopy system |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due… |
| Initiation date | May 19, 2021 |
| Report date | Jul 20, 2022 |
| 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: