Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Mon

FDA device recall Z-0011-2013 · posted 2012-10-04 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.

Action taken

The firm, Philips Healthcare, sent an "URGENT-MEDICAL DEVICE RECALL/Field Safety Notice" letter dated September 6, 2012 to its customers. The letter describes the product, problem and actions to be taken by the customer and also identifies what action Philips plans to take to remedy the issue. The customers were instructed to operate the XL and AC power instead of battery power alone; use a battery from a different date of manufacture (must not have the R-2011-12 date of manufacture code) if they need to operate the XL on battery power alone; and use an alternative source for treatment or therapy (i.e., backup defibrillator/monitor) if unable to operate with AC power alone or locate a battery with a different date of manufacture than that identified. Phillips will provide a replacement battery(s) to customers as soon as new production is available. If you need any further information or support concerning this issue, contact your local Philips representative or call Quality Specialists,Recalls at 978-687-1501 or email: debra.levasseur@philips.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MKJ

Quantity affected

2500 units

Distribution

Worldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA,

Date initiated

2012-09-11

Date posted

2012-10-04

Date terminated

2020-08-27

Location

Andover, MA

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