Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery

FDA device recall Z-1225-2014 · posted 2014-03-19 · Terminated

Recall details

Recalling firm

Philips Medical Systems North America Inc.

Reason for recall

Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency.

Action taken

Philips sent an Urgent Medical Device Recall Letter dated February 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you are have an affected device, please contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST. You can also leave a message 24 hours a day, seven days a week; a customer support representative will return your call promptly on the next business day. Customers who have an affected device will be supplied with a replacement AED device of the same model as the recalled device from Philips, free of charge. Please keep your AED in service until you receive a replacement if there are no alternative defibrillators readily available. Philips has asked Distributors to provide them with the following information within five calendar days: -The name, address, telephone number and, if available, email address of all customers who received affected devices from you or from any of your sub-distributors. -The serial numbers of any affected devices remaining in their possession, or in the possession of their sub-distributors. -Philips directed distributors with affected devices in inventory to not sell these products, but to note them as in their possession as part of their response to Philips. -Philips communicated in this letter that they are responsible for returning to Philips any units in their inventory or in the inventory of their sub-distributors, and Philips will provide instructions for returning the affected devices.

Root cause

Process control

Status

Terminated

Product code

MKJ

Quantity affected

251 units total (128 in USA and 123 untils outside USA)

Distribution

Worldwide Distribution - US Distribution including the states of AL, CA, CO, WA DC, FL, GA, HI, KS, MD, ME, MI, MS, NC, NM, NY, PA, TX, VA, WA and WI., and the countries of Australia, Austria, Canada,

Date initiated

2014-02-06

Date posted

2014-03-19

Date terminated

2017-06-29

Location

Bothell, WA

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