Recall – IPC surgical system operates at higher speed than set value

Company: Medtronic Xomed, Inc.
Date of Enforcement Report: 7/29/2020
Class II


Software 1898072 IPC upgrade v – 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.

Recall Number: Z-2673-2020


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 console.


Medtronic Xomed, Inc. on 6/12/2020. Voluntary:  Firm Initiated recall is ongoing.


673 units


U.S. Nationwide and International

62304 Software Training Course – February 23-25, 2021

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