Device recall
Z-0961-2022: Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC…
FDA device recall · Class II · Medtronic Xomed, Inc.
Key facts
| Recall number (Z-number) | Z-0961-2022 |
|---|---|
| Recall event | 89847 |
| Product | Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300 |
| Product code | ERL |
| Recalling firm | Medtronic Xomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2023 |
| 510(k) numbers | K081277, K081475 |
| FEI number | 1045254 |
At a glance
- 1–9 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