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.
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- June 12, 2020
- Terminated
- April 20, 2023
- Recall Number
- Z-2673-2020
- Quantity
- 673 units
- Firm Location
- Jacksonville, FL
Reason for Recall
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.
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, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, United Kingdom.
Lot / Code Info
Model: 1898072 Affected Lot Numbers: 0217355465, 0218377490, 0218687535, 0218928638, 0219310085,0219639840, 0217856852, 0218472653, 0218714701, 0218958034, 0219443322,0219639842, 0217858947,0218472654, 0218721203, 0218958035, 0219448447, 0219639844, 0217859045,0218665536, 0218745073, 0219004569,0219465587, 0218203285, 0218666231, 0218746389,0219201122,0219518520,0218263964, 0218666243, 0218864105, 0219255151, 0219550550, 0218293282, 0218687534, 0218900337,0219281168, 0219619754.
Root Cause
Software design
Action Taken
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 the completed Customer Confirmation Form via email to rs.entfca@medtronic.com or regular mail to: Medtronic-Xomed 6743 Southpoint Drive N Jacksonville, FL 32216 ATTN: Mike Tomberlin FCA Coordinator 4. Contact your Medtronic Field Representative to install replacement software Version 2.7.4.0 (CFN 1898073).