Z-0481-2010

Animas ezManager Max Diabetes Management System version 2.0.9

Name: Z-0481-2010 Animas ezManager Max Diabetes Management System version 2.0.9
Creator: Animas Corporation
Published: 2009-11-02
License: https://open.fda.gov/license/

Animas Corp. / initiated 2009-11-02 / Terminated / root cause: software

FDA source

Animas Corporation began a recall of Animas ezManager Max Diabetes Management System version 2.0.9 on 2009-11-02. The reason FDA records is "Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect". 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-0481-2010
Status: Terminated
Initiated: 2009-11-02
Posted: 2009-12-03
Terminated: 2010-10-27
Recalling firm: Animas Corp.
Product: Animas ezManager Max Diabetes Management System version 2.0.9
Product code: MRZ Accessories, Pump, Infusion
Reason for recall: Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
Root cause tag: software
FDA root cause: Software design
Action: Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump. The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow.
Quantity in commerce: 20,648 units
Distribution: Nationwide distribution, and Canada, Cayman Islands, and Denmark.
Product codes and lots: version 2.0.9

Product code MRZ

K080587Class IIEz Manager Max Diabetes Management SoftwareAnimas Corp. / cleared 2008-05-15

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)