Recall Z-0641-2007 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841A
| Date | Mar 22, 2007 (initiated Feb 28, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003565 | HEARTSTREAM FR2 AED, MODEL M3860A,M3861A Agilent Technologies, Inc., Dec 20, 2000 |