—#86585

Product

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 to be connected to the wall mount as a means for charging MRx devices (batteries) when stored in the wall mount. The DC power Module is also intended for use with an extension power cable, which is exclusively intended to be used to connect the DC module directly to the MRx. Philips private labels and distributes these devices which are designed and manufactured by Laerdal Medical.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K051134
Affected lot / code info: Units distributed by Philips Healthcare Inc. and shipped between September 1, 2004 and October 1, 2009.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 Medical Device Correction Notification along with the IFU will be managed by Philips representatives in each affected geography. Direct questions or concerns about the recall to your local Philips representative.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: 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 Lanka, Switzerland, Trinidad, Tobago, United Arab Emirates, and United Kingdom.

Timeline

Recall initiated: 2009-11-12
Posted by FDA: 2009-12-23
Terminated: 2012-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.