HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The defibrillator/monitor is a full

FDA device recall Z-1199-2009 · posted 2009-05-19 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

Rotary energy select switch in affected M4735A devices may fail and prevent the user from turning the device on, rendering the device unusable for monitoring and defibrillation therapy.

Action taken

An Urgent - Medical Device Recall Letter and Notice dated March 2009 were issued to affected customers. Mailings of the Urgent - Medical Device Recall Letter and Notice were handled by Philips Healthcare representatives in each affected geography. Customers were asked to follow the "Actions to be taken by customer/user" section of the Urgent - Medical Device Recall Notice. In this section, customers were instructed to remove the device from service if possible, while they await the correction of their device. If the customer is unable to remove the device from service, they are asked to identify a readily available backup device to use in the event that their device becomes unusable. All customers will be contacted by a Philips Healthcare representative to arrange for replacement of the energy select switch in the affected devices (Mandatory Field Change Order FCO86100076). Contact your local Philips Healthcare representative for additional information or support concerning this issue.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MKJ

Quantity affected

26,992

Distribution

Worldwide Distribution -- UNITED STATES, CANADA, ALBANIA, ARGENTINA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA,

Date initiated

2009-03-30

Date posted

2009-05-19

Date terminated

2012-09-04

Location

Andover, MA

Related 510(k) clearances