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.
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.
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.
The software version v2.7.3.0 has a defect that causes the console to display a different number of rotations than what actually occurs when used with Medtronic's M5 handpiece. This discrepancy could lead to inaccurate measurements but does not involve physical harm or safety risks.
Users of Medtronic Xomed IPC consoles with specific product numbers (1898001, EC300RF, EC300) that have the software version v2.7.3.0 are affected. The risk is minimal as it only affects measurement accuracy, not safety.
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.
Verify your IPC console's software version by checking the settings menu or documentation. If it is v2.7.3.0, it is affected.
No, this recall is for a software discrepancy that affects measurement accuracy but does not pose a safety risk. The hazard is low risk.
No immediate action is required. The recall is for a software version that may cause incorrect rotation counts, but it does not involve physical harm or safety risks.
The affected software version is v2.7.3.0 for the IPC console.
We’ve drafted a message you can send Medtronic Xomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0961-2022 — Medtronic Xomed Medtronic Xomed Hello, I own a Medtronic Xomed that is covered by recall Z-0961-2022 from Medtronic Xomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
