Recall Z-2673-2020— Medtronic Xomed, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Xomed, Inc., initiated 2020-06-12, terminated 2023-04-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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 cosole..
- Recalling firm
- Medtronic Xomed, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-12
- Terminated
- 2023-04-20
- Firm location
- Jacksonville, FL, United States
Product description
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.
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 cosole.
Data sourced from openFDA. This site is unofficial and independent of the FDA.