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 Recall Z-0562-2010 · Posted 2009-12-23
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Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-11-12
Date Terminated2012-01-25
Product Quantity3,265 units
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.
Firm 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.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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