# FDA recall Z-0961-2022

> **Medtronic Xomed, Inc.** · Class II · device recall initiated 2021-12-15.

## 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

## Reason for 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.

## Distribution

International distribution country of Japan.

## Key facts

- **Recall number:** Z-0961-2022
- **Recalling firm:** Medtronic Xomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-15
- **Report date:** 2022-04-27
- **Termination date:** 2023-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jacksonville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0961-2022

## Citation

> AI Analytics. FDA recall Z-0961-2022. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0961-2022. Source: US FDA. Licensed CC0.

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