Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1006-2009 · Posted 2009-03-09

Recalling FirmWelch Allyn Protocol, Inc
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-12-15
Date Terminated2012-03-19
Product Quantity10, 735

Reason for Recall

Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;

Firm Action

Welch Allyn sent a Customer Recall Notice dated February 26, 2009, to all customers (customer list supplied by distributors). Welch Allyn will upgrade all units with software version 2.02 and lower to version 2.06.02 by Proc. AED10 Prod Service Min HW/SW Update Rev. E 820-0178-00.

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.

↑