Medtronic Xomed, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2673-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
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.
Class II
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.
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.
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.
Voluntary: Firm initiated