Recall Z-1128-2007 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
| Date | Aug 7, 2007 (initiated Jun 11, 2007) |
| Status | Terminated |
| Reason | The ECG signal may become unusable to assess patient condition and need for therapy. |
| Root cause | Nonconforming Material/Component |
| Action | Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units. |
| Quantity | 312 units |
| Distribution | Worldwide, including USA, Canada, Australia, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Kuwait, Macau, Poland, Portugal, Romania, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, UK, and Venezuela. |
| 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 |