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Terminated

Welch Allyn AED 10 Automated External Defibrillator

FDA Recall Z-1005-2009 · Posted 2009-03-10

Recalling FirmWelch Allyn Protocol, Inc
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-12-15
Date Terminated2012-02-15
Product Quantity89 units

Reason for Recall

Potential for device to shut down prematurely under certain circumstances.

Firm Action

On 4/13/07 the firm released Service Bulletin part no. 810-2614-00, SB - AED 10 S/W V020600 DOWNGRADE to V020500. That mandatory bulletin, for units with software version 2.06.00 and up indicates that all returning AED 10 units shall have their software version downgraded to 2.05.00.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: USA, Belgium, Canada, France, Ireland, Israel, Mexico, and United Kingdom.

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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