Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
FDA device recall Z-1006-2009 · posted 2009-03-09 · Terminated
Recall details
- Recalling firm
- Welch Allyn Protocol, Inc
- Reason for recall
- Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;
- Action taken
- Welch Allyn sent a Customer Recall Notice dated February 26, 2009, to all customers (customer list supplied by distributors). Welch Allyn will upgrade all units with software version 2.02 and lower to version 2.06.02 by Proc. AED10 Prod Service Min HW/SW Update Rev. E 820-0178-00.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 10, 735
- Distribution
- Worldwide Distribution.
- Date initiated
- 2008-12-15
- Date posted
- 2009-03-09
- Date terminated
- 2012-03-19
- Location
- Beaverton, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JUMP START, MODEL 970300 (K021168) | Medical Research Laboratories, Inc. | 2002-06-26 |