Device recall
Z-0549-2022: eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-0549-2022 |
|---|---|
| Recall event | 89489 |
| Product | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the… |
| Product code | MSX |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2024 |
| FEI number | 3016618143 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database