Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10

FDA device recall Z-0129-2008 · posted 2007-11-06 · Terminated

Recall details

Recalling firm

Welch Allyn Protocol, Inc

Reason for recall

Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient

Action taken

The firm issued a press release on 10/30/07, and has set up a call center for customers, and plans to send three (3) certified mailings to notify affected customers, alert them of the issue, and provide instructions on how to return their device. The first letter dated 10/26/07 was sent via certified mail to customers on 10/26/07. The letter informs customers of the firm recalling the product to correct faulty capacitors on the circuit board, and which could result in a malfunction that prevents or delays delivery of a defibrillating shock. The letter indicates the faulty AED10 devices were manufactured between 3/29/07 and 8/9/07. The letter also indicates the serial numbers affected, and where the serial number is located - upper left hand corner of the back panel of the device. In addition the letter includes a response form, the firm's contact information, and indicates that the firm will exchange the recalled defibrillator with a replacement and new five (5) year warranty.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MKJ

Quantity affected

1,794 distributed - 1176 in US and 618 internationally

Distribution

Worldwide.

Date initiated

2007-10-26

Date posted

2007-11-06

Date terminated

2011-11-09

Location

Beaverton, OR

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