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U.S. Department of Health and Human Services

Class 2 Device Recall Component of integrated Power Console (IPC)

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 Class 2 Device Recall Component of integrated Power Console (IPC)see related information
Date Initiated by FirmJune 12, 2020
Create DateJuly 21, 2020
Recall Status1 Terminated 3 on April 20, 2023
Recall NumberZ-2673-2020
Recall Event ID 85886
Product Classification Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
ProductSoftware 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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information ContactMike Tomberlin
904-281-2769
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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).
Quantity in Commerce673 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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