FDA-Device2022-04-27Class II
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
Medtronic Xomed, Inc.
Hazard
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.
Sold states
International distribution country of Japan.
Affected count
1447 units
Manufactured in
6743 Southpoint Dr N, Jacksonville, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0961-2022Don't want to check this manually?
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