Animas ezManager Max Diabetes Management System version 2.0.9
This recall has been terminated (originally issued December 3, 2009).
- Company
- Animas Corporation
- Recall Initiated
- November 2, 2009
- Posted
- December 3, 2009
- Terminated
- October 27, 2010
- Recall Number
- Z-0481-2010
- Quantity
- 20,648 units
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
Distribution
Nationwide distribution, and Canada, Cayman Islands, and Denmark.
Lot / Code Info
version 2.0.9
Root Cause
Software design
Action Taken
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.
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