Drug recall
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting…
FDA recall event 85886 · Class II · Medtronic Xomed, Inc.
Key facts
| Event ID | 85886 |
|---|---|
| Recall numbers | Z-2673-2020 |
| Recalling firm | Medtronic Xomed, Inc. |
| Product type | Devices |
| Products | Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the… |
| Initiation date | Jun 12, 2020 |
| Report date | Jul 29, 2020 |
| Termination date | Apr 20, 2023 |
| City | Jacksonville |
| State | FL |
| Country | United States |
| FEI number | 1045254 |
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: