HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J (HeartStart MRxE). Note: M3536JIMRx
FDA device recall Z-1795-2009 · posted 2009-07-24 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- External transport use environments, the mechanical/electrical connection between the pads therapy cable including pads/CPR cable and the MRx/MRxE may wear at an increased rate ultimately prevent the device from sensing that the pads therapy cable is connected, or, cause the device to inappropriately identify external paddles or internal paddles when the pads therapy cable is connected
- Action taken
- Philips Healthcare issued an "Urgent - Voluntary Medical Device Correction" notice dated July 2009 providing information on the affected device, namely, how to identify the affected devices and instructions on actions to be taken. Consignees are asked to contact their local Philips representative to confirm receipt of the recall letter and to arrange for service. Contact Philips Healthcare for further questions at 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- mkj
- Quantity affected
- 11,579 units
- Distribution
- Worldwide Distribution -- United States, Afghanistan, Albania, Australia, Austria, Bahrain, Brazil, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Icel
- Date initiated
- 2009-07-07
- Date posted
- 2009-07-24
- Date terminated
- 2013-02-19
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTART MRX, MODEL M3535A (K031187) | Philips Medical Systems | 2003-08-27 |