FDA recall Z-0961-2022

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

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

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