HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Reported: April 5, 2017 Initiated: February 24, 2017 #Z-1417-2017
Product Description
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Reason for Recall
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 97,794 total ( 47,362 US and 50,429 OUS)
- Distribution
- Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, ARGENTINA, ARUBA, AUSTRALIA,AUSTRIA,AZERBAIJAN,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA,BOSNIA AND HERZEGOWINA, BRAZIL,BRUNEI DARUSSALAM, BULGARIA,CAMBODIA,CANADA,CHILE,CHINA,COLOMBIA,COSTA RICA, CROATIA (local name: Hrvatska),CYPRUS,CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC,ECUADOR,EGYPT,EL SALVADOR, ESTONIA, ETHIOPIA,FINLAND,FRANCE,GABON,GERMANY,GHANA,GREECE, GUADELOUPE, HONG KONG,HUNGARY,ICELAND,INDIA, INDONESIA,IRAN (ISLAMIC REPUBLIC OF),IRAQ,IRELAND,ISRAEL,ITALY,JAPAN, JORDAN, KAZAKHSTAN, KENYA,KOREA, REPUBLIC OF,KUWAIT,LAOS,LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA,LITHUANIA,LUXEMBOURG, MACAU, MACEDONIA,MALAYSIA,MALTA,MAURITIUS,MEXICO,MONGOLIA, MOROCCO, MOZAMBIQUE,MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES,NEW CALEDONIA,NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA,PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL,QATAR,REUNION,ROMANIA,RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA,SOUTH AFRICA,SPAIN,SRI LANKA, SWEDEN,SWITZERLAND,TAIWAN, PROVINCE OF CHINA,TANZANIA, UNITED REPUBLIC OF,THAILAND,TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN,UGANDA,UKRAINE,UNITED ARAB EMIRATES,UNITED KINGDOM,UZBEKISTAN,VENEZUELA,VIET NAM,YEMEN.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9. Recalled by Philips North America, LLC. Units affected: 97,794 total ( 47,362 US and 50,429 OUS).
Why was this product recalled? ▼
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2017. Severity: Critical. Recall number: Z-1417-2017.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11