FDA-Device2020-07-29Class II
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.
Medtronic Xomed, Inc.
Hazard
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.
Sold states
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.
Affected count
673 units
Manufactured in
6743 Southpoint Dr N, N/A, Jacksonville, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2673-2020Don't want to check this manually?
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