FDAJune 12, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

medtronic xomedmedtronic

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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