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Terminated

Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")

FDA Recall Z-1007-2009 · Posted 2009-03-10

Recalling FirmWelch Allyn Protocol, Inc
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-12-15
Date Terminated2012-03-19
Product Quantity14,012 devices

Reason for Recall

Potential for device to deliver less than the programmed energy.

Firm Action

Welch Allyn notified distributors by letter on 12/15/2008 requesting that they notify their customers. Welch Allyn sent an Urgent: Medical Device Recall letter to distributors and customers on February 26, 2009.

Root Cause

Process control

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021168JUMP START, MODEL 970300Medical Research Laboratories, Inc. · 2002-06-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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