Z-2673-2020Class II

Software 1898072 IPC upgrade v 2.7.3.0 -

Name: Z-2673-2020 Software 1898072 IPC upgrade v 2.7.3.0 -
Creator: Medtronic Xomed, Inc.
Published: 2020-06-12
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2020-06-12 / Terminated / root cause: software

FDA source

Medtronic Xomed, Inc. began a recall of 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... on 2020-06-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2673-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-12
Posted: 2020-07-21
Terminated: 2023-04-20
Recalling firm: Medtronic Xomed, Inc.
Product: 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.
Product code: ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
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.
Root cause tag: software
FDA root cause: Software design
Action: On June 12th 2020 the firm send a notification to its consignees giving then the following instructions: Actions Required: 1. Immediately locate, quarantine, and return any software cards for Software 1898072 IPC Upgrade v2.7.3.0. Instructions for return are found on the Consignee Confirmation form. 2. Check the software version currently installed on your IPC Console and complete the Customer Confirmation Form. If your IPC has software v2.7.3.0 installed, do not use this console with M5 handpiece. Please record your console serial number and the software version currently loaded. 3. Return the completed Customer Confirmation Form via email to [email protected] or regular mail to: Medtronic-Xomed 6743 Southpoint Drive N Jacksonville, FL 32216 ATTN: Mike Tomberlin FCA Coordinator 4. Contact your Medtronic Field Representative to install replacement software Version 2.7.4.0 (CFN 1898073).
Quantity in commerce: 673 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2673-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2673-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21

Product code ERL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)