High FDA (Devices)·Z-2673-2020·Announced 2020-07-29

Medtronic Xomed IPC Software Upgrade Recalled for Speed Control Issue

Medtronic Xomed is recalling IPC software upgrade v 2.7.3.0 because the M5 Microdebrider may rotate faster than the set value.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a surgical instrument operating at higher speeds than set, which poses a risk of harm to patients during procedures, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Medtronic Xomed, Inc. is recalling the Software 1898072 IPC upgrade v 2.7.3.0. This software is used with the Integrated Power Console (IPC) system, which is indicated for the incision, cutting, removal, drilling, and sawing of soft and hard tissue and bone in surgical procedures.

The recall was initiated after internal testing of the next-generation IPC prototype revealed that the M5 Microdebrider was rotating at a higher speed than the value set on the console. This discrepancy was identified during internal testing execution.

The recall affects 673 units distributed worldwide, including nationwide distribution in the United States and in various countries such as Australia, Canada, China, and the United Kingdom. Specific lot numbers are listed in the agency's recall record. Users of this software should contact Medtronic Xomed for instructions on how to proceed.

The recalled product

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.
Manufacturer: Medtronic Xomed, Inc.
Category: Medical Device — Surgical Software
Hazard: speed-control-failure
Affected units: 673

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model: 1898072 Affected Lot Numbers: 0217355465
0218377490
0218687535
0218928638
0219310085
0219639840
0217856852
0218472653
0218714701
0218958034
0219443322
0219639842
0217858947
0218472654
0218721203
0218958035
0219448447
0219639844
0217859045
0218665536

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Same manufacturer · Medtronic Xomed, Inc.

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