FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web
FDA device recall Z-1594-05 · posted 2005-10-01 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- Reason for recall
- Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.
- Action taken
- On 8/30/05, the firm initiated the recall and its notification was via web postings and phone calls requesting discontinuation of the FreeStyle CoPilot from the website. A follow-up letter will be sent to registered users advising them of the issues and instructing them to not use CoPilot.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFR
- Quantity affected
- Product is downloadable software
- Distribution
- Software, distributed from website via clicking through an agrement to use only for informational purposes, and not as a substitute for professional medical advice treatment or diagnosis.
- Date initiated
- 2005-08-30
- Date posted
- 2005-10-01
- Date terminated
- 2006-05-16
- Location
- Alameda, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONNECT DATA MANAGEMENT SYSTEM (K994433) | Abbott Diabetes Care, Inc. | 2000-05-05 |