Recall Z-0961-2022— Medtronic Xomed, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Xomed, Inc., initiated 2021-12-15, terminated 2023-06-09. It names 2 FDA 510(k) clearances: K081475, K081277. 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: 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
- Medtronic Xomed, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-12-15
- Terminated
- 2023-06-09
- Firm location
- Jacksonville, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K081475 — ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
- K081277 — XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.