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

FDA device recall Z-0472-2011 · posted 2010-11-26 · Terminated

Recall details

Recalling firm

Philips Medical Systems

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.

Action taken

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

Status

Terminated

Product code

MKJ

Quantity affected

13,355 units

Distribution

Worldwide Distribution: Throughout the USA, and to the following countries: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, CHI

Date initiated

2010-05-28

Date posted

2010-11-26

Date terminated

2013-09-13

Location

Seattle, WA

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