Lower risk Medical device recall · FDA · Published December 15, 2021

Medtronic Xomed Recalls IPC Software 1898072 v2.7.3.0: Rotation Count Mismatch with M5

Medtronic Xomed recalls specific IPC console software versions that may cause incorrect rotation counts when used with M5 handpieces. Affected units include certain console models with product numbers 1898001, EC300RF, and EC300. No immediate action is required as the hazard is a minor software discrepancy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0961-2022Medical device Medtronic Xomed ›

Lower-risk recall

As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.

Take action

Contact the company

Recalling firmMedtronic Xomed, Inc.6743 Southpoint Dr N · Jacksonville, FL 32216-6218

✎ GovInfoNow plain-language explainer

Medtronic Xomed is recalling specific software versions (v2.7.3.0) for their IPC consoles that may cause incorrect rotation counts when used with their M5 handpieces. This is a software discrepancy that does not pose a safety risk but could lead to inaccurate measurements. Read more at govinfonow.com/recall/61431-medtronic-xomed-recalls-ipc-software-1898072-v2-7-3-0.

Source Summary by GovInfoNow · govinfonow.com/recall/61431-medtronic-xomed-recalls-ipc-software-1898072-v2-7-3-0 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0961-2022

Cite this page

“Medtronic Xomed Recalls IPC Software 1898072 v2.7.3.0: Rotation Count Mismatch with M5.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61431-medtronic-xomed-recalls-ipc-software-1898072-v2-7-3-0. Based on FDA recall #Z-0961-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0961-2022%22&limit=1).

The FDA announced on Dec. 15, 2021, that Medtronic Xomed, Inc. is recalling Software 1898072 IPC upgrade v 2.7.3.0 for its integrated power consoles due to a defect causing rotation discrepancies. The recall affects 1,447 units distributed in Japan.

How to tell if you have it

Medtronic Xomed
Software 1898072 IPC upgrade v 2.7.3.0
CONSOLE 1898001 IPC, Product Number 1898001
CONSOLE IPC REFURB, Product Number EC300RF
MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
UPC 00613994752246
UPC 00613994614629
UPC 00613994750167

The hazard

GovInfoNow's records show the defect results in a difference between the set number of rotations and the actual number of rotations in a specific mode when used with the company's M5 handpiece. The FDA said this occurred because the integrated power console (authentication number: 222ACBZX00018000) was used with software version v2.7.3.0.

Context

GovInfoNow's records show Medtronic Xomed, Inc. has had 11 other recalls since Nov. 13, 2019. Other recent recalls of similar products include the Medtronic Xomed IPC POWEREASE System Recall (July 17, 2025) and the Medtronic Xomed NIM Vital Nerve Monitoring System recall (March 10, 2025). Other recent recalls of similar products include the Philips Azurion 5 M12 System Software Recalls (Jan. 26, 2026) and the Medicrea IB3D PL Instruments Set Recall (Oct. 29, 2025).

How to tell if you have this one

Check if your IPC console has product number 1898001, EC300RF, or EC300 with software version v2.7.3.0. The affected units have specific serial numbers listed in the recall notice.

Brand
Medtronic Xomed
Product
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your IPC console's software version by checking the settings menu or documentation. If it is v2.7.3.0, it is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Dec 15, 2021Firm started the recall
Apr 20, 2022FDA classified it Class II
Apr 27, 2022Published in FDA’s Enforcement Report
Jun 9, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61431-medtronic-xomed-recalls-ipc-software-1898072-v2-7-3-0">Medtronic Xomed Recalls IPC Software 1898072 v2.7.3.0: Rotation Count Mismatch with M5 (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0961-2022 (December 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0961-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.