Terminated

HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge.

FDA Recall Z-0472-2011 · Posted 2010-11-26

Recalling FirmPhilips Medical Systems

Recall StatusTerminated

Product CodeMKJ

Date Initiated2010-05-28

Date Terminated2013-09-13

Product Quantity13,355 units

Reason for Recall

Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.

Firm Action

Philips Medical Systems issued an Urgent Medical Device Recall letter dated May 28, 2010 identifying the affected device and actions to be taken. Customers were instructed to review their inventory for affected devices. If affected devices are found, the customer should contact Philips to arrange for a replacement device. The customer should also run a battery insertion test. If the device passes the test, the AED may remain in service until a replacement is received. For further information, contact Philips at 1 800 263-3342, option 6.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: Throughout the USA, and to the following countries: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, FINLAND, FRANCE, GERMANY, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIETNAM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051632PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841APhilips Medical Systems · 2005-10-05 K014157HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841APhilips Medical Systems · 2002-01-17 K013425HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841APhilips Medical Systems · 2002-01-14 K003819HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870AAgilent Technologies, Inc. · 2001-05-02 K003565HEARTSTREAM FR2 AED, MODEL M3860A,M3861AAgilent Technologies, Inc. · 2000-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.