Class 2 Device Recall Philips Medical Systems

• Date Initiated by Firm: November 12, 2009
• Date Posted: December 23, 2009
• Recall Status: Terminated on January 25, 2012
• Recall Number: Z-0562-2010
• Recall Event ID: 53820
• 510(K)Number: K051134
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• 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.
• Code Information: Units distributed by Philips Healthcare Inc. and shipped between September 1, 2004 and October 1, 2009.
• Recalling Firm/ Manufacturer: Philips Healthcare Inc.; 3000 Minuteman Road; Andover MA 01810
• For Additional Information Contact: Michael Miller Jr.; 978-687-1501
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 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.
• Quantity in Commerce: 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 Lanka, Switzerland, Trinidad, Tobago, United Arab Emirates, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ