ClearanceBrief
Recall Z-0473-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)

Philips Medical Systems

HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.

DateNov 26, 2010 (initiated May 28, 2010)
StatusTerminated
ReasonFailure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
Root causeNonconforming Material/Component
ActionPhilips 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.
Quantity1,478 units
DistributionWorldwide 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, I
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K003565HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
Agilent Technologies, Inc., Dec 20, 2000
K003819HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
Agilent Technologies, Inc., May 2, 2001
K013425HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
Philips Medical Systems, Jan 14, 2002
K014157HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
Philips Medical Systems, Jan 17, 2002
K051632PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
Philips Medical Systems, Oct 5, 2005