Reported Apr 27, 2022 · Terminated
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC…
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
- IPC System
a) CONSOLE 1898001 IPCProduct Number 1898001b) CONSOLE IPC REFURBProduct Number EC300RFc) MASTER CONSOLE EC300 LEGEND EHSProduct Number EC300
- Lot codes and dates
a) Product Number 1898001GTIN 00613994752246
- Lot Serial Numbers
514 of 514 codes
721587216272167721787217672205722067220872234723237231572326723397234072342723727240472419724227247172509724927278872818728197281572816728387284372639726077263072632731177311473115731227320473206732187355473354733557335873359733517338473408734107341673420734217342773431734327343373430734347350873510
- Lot Serial Numbers
51010512855140751477515335155951693517295226652282523035246452586537045383154082544485447554487548205561457027 c) Product Number EC300GTIN 00613994750167
- Lot Serial Numbers
911 of 911 codes
520055215452158521595218952190522005221252248522505225452258523125231352315523245237452377523805238752398525895259052595529255306353065530675306853086530895309053092530945311353155536165361753618536205362253623536335366053661536625366353664537175381753818538715390053901539225392353924539725397453976
- Amount recalled
- 1447 units
Why it was recalled
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.
This product could cause temporary or reversible health problems — stop using it.
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