Recall Z-2673-2020 · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Medtronic Xomed, Inc.

Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.

Date	Jun 12, 2020
Status	Terminated
Reason	During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.
Root cause	Software design
Action	On June 12th 2020 the firm send a notification to its consignees giving then the following instructions: Actions Required: 1. Immediately locate, quarantine, and return any software cards for Software 1898072 IPC Upgrade v2.7.3.0. Instructions for return are found on the Consignee Confirmation form. 2. Check the software version currently installed on your IPC Console and complete the Customer Confirmation Form. If your IPC has software v2.7.3.0 installed, do not use this console with M5 handpiece. Please record your console serial number and the software version currently loaded. 3. Return
Quantity	673 units
Distribution	Worldwide distribution - US Nationwide distribution including in the states of AL, AK, AZ, AR, CA,CO, CT, FL, GA, HI, ID,IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, TN, TX, UT, VA, WV, WA, WI. The countries of Australia, Austria, Belgium, Canada, China
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.