Reported Jul 29, 2020 · Terminated
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal,…
Medtronic Xomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
- Software 1898072 IPC upgrade v 2.7.3.0 -
- Product UsageThe IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures
- Lot codes and dates
- Model1898072
- Affected Lot Numbers
02173554650218377490021868753502189286380219310085021963984002178568520218472653021871470102189580340219443322021963984202178589470218472654021872120302189580350219448447021963984402178590450218665536021874507302190045690219465587021820328502186662310218746389021920112202195185200218263964021866624302188641050219255151021955055002182932820218687534021890033702192811680219619754
- Amount recalled
- 673 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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