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 fibrillation.
FDA Recall Z-1257-2010 · Posted 2010-04-08
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Reason for Recall
Firm Action
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide 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, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MAURITIUS, MEXICO, NETHERLANDS, NETHERLANDS ANTILLES, NEW ZEALAND, NICARAGUA, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SAINT LUCIA, SAIPAN, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and VIRGIN ISLANDS.
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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