Drug recall
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
FDA recall event 93638 · Class II · Philips North America
Key facts
| Event ID | 93638 |
|---|---|
| Recall numbers | Z-0731-2024, Z-0732-2024 |
| Recalling firm | Philips North America |
| Product type | Devices |
| Products | (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436, (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. |
| Initiation date | Nov 28, 2023 |
| Report date | Jan 24, 2024 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3006648320 |
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: