Welch Allyn AED 10 Automated External Defibrillator
FDA device recall Z-1005-2009 · posted 2009-03-10 · Terminated
Recall details
- Recalling firm
- Welch Allyn Protocol, Inc
- Reason for recall
- Potential for device to shut down prematurely under certain circumstances.
- Action taken
- On 4/13/07 the firm released Service Bulletin part no. 810-2614-00, SB - AED 10 S/W V020600 DOWNGRADE to V020500. That mandatory bulletin, for units with software version 2.06.00 and up indicates that all returning AED 10 units shall have their software version downgraded to 2.05.00.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 89 units
- Distribution
- Worldwide distribution: USA, Belgium, Canada, France, Ireland, Israel, Mexico, and United Kingdom.
- Date initiated
- 2008-12-15
- Date posted
- 2009-03-10
- Date terminated
- 2012-02-15
- Location
- Beaverton, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JUMP START, MODEL 970300 (K021168) | Medical Research Laboratories, Inc. | 2002-06-26 |