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U.S. Department of Health and Human Services

Class 2 Device Recall ezManager Max Diabetes Management System version 2.0.9

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 Class 2 Recall
ezManager Max Diabetes Management System version 2.0.9
see related information
Date Posted December 03, 2009
Recall Status1 Terminated on October 27, 2010
Recall Number Z-0481-2010
Recall Event ID 53748
Premarket Notification
510(K) Number
K080587 
Product Classification Accessories, Pump, Infusion - Product Code MRZ
Product Animas ezManager Max Diabetes Management System version 2.0.9
Code Information version 2.0.9
Recalling Firm/
Manufacturer
Animas Corporation
200 Lawrence Dr
West Chester, Pennsylvania 19380-3428
For Additional Information Contact Customer Services
866-423-4087
Manufacturer Reason
for Recall
Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MRZ and Original Applicant = ANIMAS CORP.
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