Recall – Software defect causes incorrect number of rotations

Company: Medtronic Xomed, Inc.
Date of Enforcement Report: 4/27/2022
Class II

PRODUCT

Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300

Recall Number:

Z-0961-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

Medtronic Xomed, Inc. on 4/27/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

1447 units

DISTRIBUTION

International

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