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 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.

Recall number

Z-0562-2010

Recalling firm

Philips Healthcare Inc.

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.

Status

Terminated

Initiated

2009-11-12

Posted

2009-12-23

Terminated

2012-01-25

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 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

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.

Lot, serial or model codes

Units distributed by Philips Healthcare Inc. and shipped between September 1, 2004 and October 1, 2009.

510(k) numbers

["K051134"]

PMA numbers

not on file

Product code

MKJ

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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