Recall Z-0562-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
Philips HeartStart Vehicle Wall Mount, Model M5528A with Philips HeartStart DC Power Module, Model M5529A. The HeartStart MRx portable external defibrillator has optional accessories which include a wall mount and a DC power module. The wall mount is intended for storage and transport of MRx devices in land based transport vehicles. The power module is an additional optional accessory intended
| Date | Dec 23, 2009 (initiated Nov 12, 2009) |
| Status | Terminated |
| Reason | HeartStart Vehicle Wall Mount (Model M5528A) with DC Power Module (Model M5529A)--Incorrect wiring during installation by user may result in a smoke or fire hazard. |
| Root cause | Device Design |
| Action | Philips Healthcare, Inc. notified customers by an "URGENT - Voluntary Medical Device Correction" letter, plus revised Instructions For Use (IFU) for the Vehicle Wall Mount accessory and the DC Power Module accessory of the HeartStart MRx which includes a revised description of correct installation and verification of performance. Customers were asked to follow the Actions in the customer/user section of the Urgent - Voluntary Medical Device Correction Notification. In this section, customers were given the instructions to correct their devices. Distribution of the Urgent - Voluntary Me |
| Quantity | 3,265 units |
| Distribution | Class II Recall -- Worldwide Distribution -- United States, Canada, Australia, Brazil, China, France, Germany, Hong Kong, Iceland, India, Indonesia, Italy, Japan, Jordan, Kenya, Libyan Arab Jamahiriya, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Saudi Arabia, Spain, Sri Lank |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051134 | HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A Philips Medical Systems, Sep 8, 2005 |