Welch Allyn Recalls Some AED 10 AEDs

Welch Allyn Protocol, Inc. of Beaverton, Ore., has recalled AED 10(TM) Automatic External Defibrillators manufactured between March 29, 2007 and Aug. 9, 2007, with part numbers 970302E, 970308E, 970310E, and 970311. This is classified as a Class 1 Recall by FDA, which posted a notice of it on the MedWatch Web site.

The notice said the recalled devices "may experience failure or unacceptable delay in analyzing a patient's ECG resulting in possible failure to deliver the appropriate therapy." Welch Allyn's Oct. 30 press release said it has observed 49 failures in the manufacture and has received three customer complaints; the company said a defective capacitor made by a vendor at one factory and used on two lots of printed circuit board assemblies is the faulty part. The failures depends on the capacitor's location on the circuit board -- it has shown up as a flashing status indicator, excessive battery drain, continuous device resets, and no shock advised with a ventricular fibrillation input, Welch Allyn said.

Customers may call Welch Allyn's Technical Support, 800-462-0777, to arrange for a replacement AED that will include a new five-year warranty. The company has set up a call center for customers and will send three certified mailings to notify affected customers.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Comply with OSHA’s Electronic Recordkeeping Requirements

    Collect relevant incident data and generate accurate OSHA 300, 300A, and 301 regulatory reports, including 300A CSV files for easy electronic submission to OSHA.

  • Complete Online Safety Training Courses

    Deliver state-of-the art, online safety training courses to your organization with IndustrySafe Training Management Software. Generate reports to track training compliance and automatically notify learners of upcoming or overdue classes.

  • Easy to Use Safety Inspection App

    Conduct inspections on the go with IndustrySafe’s mobile app. Complete safety audits at job sites and remote locations—with or without web access.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus