Animas ezManager Max Diabetes Management System version 2.0.9
FDA device recall Z-0481-2010 · posted 2009-12-03 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MRZ
- Quantity affected
- 20,648 units
- Distribution
- Nationwide distribution, and Canada, Cayman Islands, and Denmark.
- Date initiated
- 2009-11-02
- Date posted
- 2009-12-03
- Date terminated
- 2010-10-27
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE (K080587) | Animas Corp. | 2008-05-15 |