Drug recall
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and…
FDA recall event 89203 · Class II · Philips North America Llc
Key facts
| Event ID | 89203 |
|---|---|
| Recall numbers | Z-0416-2022 |
| Recalling firm | Philips North America Llc |
| Product type | Devices |
| Products | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the… |
| Initiation date | Nov 19, 2021 |
| Report date | Dec 29, 2021 |
| Termination date | Feb 7, 2024 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3016618143 |
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: