ClearanceBrief
Recall Z-1257-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)

Philips Healthcare Inc.

AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Philips product lines, as well as Respironics/Philips products, Dixtel owned products and Dixtal (formerly Novametrix or Respironics/Novametrix products. Philips HeartStart MRx Defibrillator/Monitor model number M3535A, ID number 861288. For use for the termination of ventricular tachycardia and ventricular fib

DateApr 8, 2010 (initiated Nov 19, 2009)
StatusTerminated
ReasonPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock.
Root causeNonconforming Material/Component
ActionPhilips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside plug. The issue affects medical device power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug ("taller bridge" design). Medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected. Urgent Medical Device Correction let
Quantity16,705
DistributionWorldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, Aruba, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, Denmark, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONES
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K051134HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
Philips Medical Systems, Sep 8, 2005