HeartStart FR2+ Defibrillator
FDA device recall Z-0308-2007 · posted 2006-12-27 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation
- Action taken
- On 12/19/06 the firm sent letters via return receipt to all domestic customers. The letter advised customers of the issue and if the user encounters the problem, to press the button again with additional force. The users are to contact Philips for replacement. The devices can be used until the user receives a replacement.
- Root cause
- Process design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 2000 units
- Distribution
- Distribution is worldwide.
- Date initiated
- 2006-12-19
- Date posted
- 2006-12-27
- Date terminated
- 2011-06-22
- Location
- Seattle, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTREAM FR2 AED, MODEL M3860A,M3861A (K003565) | Agilent Technologies, Inc. | 2000-12-20 |