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Terminated

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

FDA Recall Z-1389-2009 · Posted 2009-06-23

Recalling FirmWelch Allyn Protocol, Inc
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-02-26
Date Terminated2012-03-07
Product QuantityIssue #1: 4568 units; Issue#2: 5186 units

Reason for Recall

Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.

Firm Action

Welch Allyn sent an Urgent Medical Device Recall letter dated February 26, 2009 to all distributors and customers, describing 5 failure modes. Customers were instructed to respond to the letter by calling 888-345-5356, and decide on replacement or discounted new purchase.

Root Cause

Component design/selection

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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