Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841
FDA device recall Z-0641-2007 · posted 2007-03-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Failure of tactile switches on one of two printed circuit board assemblies (PCBA) used in the FR2+ device. Potential delay or prevention of shock treatment due to PCBA board contamination, causing intermittent switch operation.
- Action taken
- On 02/28/2007 the firm sent letters via return receipt to all domestic and foreign customers. The letter advises the customer of the issue and if the user encounters the problem, to press the button again with additional force. In addition, the firm sent with the letter a new Quick Reference Card. Customers are instructed to replace the old Quick Reference Card with the new one which instructs them to press 'On' and 'Shock' buttons firmly.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 9099 units
- Distribution
- Distribution is worldwide. Devices are used by first responders (EMT, EMS, Fire and Police personnel, etc.), and by trained personnel on commercial airlines and business offices.
- Date initiated
- 2007-02-28
- Date posted
- 2007-03-22
- Date terminated
- 2013-11-13
- Location
- Seattle, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTREAM FR2 AED, MODEL M3860A,M3861A (K003565) | Agilent Technologies, Inc. | 2000-12-20 |