CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC recalled
Medtronic Xomed is recalling Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC, distributed nationwide in the US. The recall was initiated on 12 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2673-2020
- FDA event ID
- 85886
- Recalling firm
- Medtronic Xomed, Jacksonville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2020
- FDA classified
- 21 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 12 Jun 2020 | Recall initiated by company | |
| 21 Jul 2020 | Classified by FDA | +39 days |
| 29 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Xomed
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|---|---|---|---|---|---|
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| Device | CLASS I | NIM EMG Endotracheal Tube, Part Numbers: a) recalled by Medtronic Xomed | Medtronic Xomed | Other | Nationwide |
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