Recall Z-0062-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
HeartStart XL Defibrillator/Monitor, Model: M4735A
| Date | Oct 25, 2007 (initiated Sep 4, 2007) |
| Status | Terminated |
| Reason | Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly. |
| Root cause | Package design/selection |
| Action | Philips Medical notified accounts (Distributors/Healthcare Customers) by letter dated 9/4/07. Users are requested if possible to remove the unit from service. Firm will have Field representative conduct correction. |
| Quantity | 147 boards |
| Distribution | Puerto Rico, Canada, Argentina, Australia, Brazil, China, Domincan Republic, Czech Republic, Hong Kong, India, Japan, Korea, Macau, Singapore, Spain, South Africa, Slovenia, Sweden, Switzerland, Ireland, UK, France, Kuwait, Poland, and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021453 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A Philips Medical Systems, Jul 3, 2002 |