FDA Recalls MRL/Welch Allyn AED 20

FDA has issued a Class I recall for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509.

These devices are used by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The recalled devices may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

FDA advises healthcare professionals and patients to stop using the recalled product and contact the manufacturer to obtain a loaner AED 20™ at no cost while their unit is being serviced. Welch Allyn says it will pay all costs associated with the upgrade required to correct the issue as well as shipping and handling of the devices. Customers may call the manufacturer at 1-800-462-0777. Welch Allyn said it sent recall letters on Aug. 29, 2007 to its customers who purchased these devices.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/MedWatch/report.htm, by regular mail through a postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm, or by fax at 1-800-FDA-0178.

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.

  • 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.

  • Analyze Incident Data and Maintain OSHA Compliance

    Collect relevant incident data, analyze trends, and generate accurate regulatory reports, including OSHA 300, 300A, and 301 logs, through IndustrySafe’s extensive incident reporting and investigation module.

  • Industry Safe
comments powered by Disqus