Software 1898072 IPC upgrade v 2 — Class II medical device recall Z-0961-2022
Terminated recall by Medtronic Xomed, Inc., reported 2022-04-27. As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with
| Recall number | Z-0961-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2021-12-15 |
| Classified | 2022-04-20 |
| Reported by FDA | 2022-04-27 |
| Terminated | 2023-06-09 |
| Countries outside the US | JP |
| Quantity | 1,447 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00613994614629, 00613994750167, 00613994752246 |
| Serial numbers | 51010, 51285, 51407, 51477, 51533, 51559, 51693, 51729, 52005, 52154, 52158, 52159, 52189, 52190, 52200, 52212, 52248, 52250, 52254, 52258, 52266, 52282, 52303, 52312, 52313 and 475 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0961-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.