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External defibrillators voluntarily recalled

Device Regulation Alert: Safety, Compliance and Reimbursement News, November 12, 2007

The FDA and Welch Allyn announced the company's voluntary Class I recall of automatic external defibrillators. The company stated in an October 30 press release that it was voluntarily issuing a worldwide recall of a specific number of AED10 Automatic External Defibrillators because of potential failure to resuscitate a patient. The FDA's announcement explains that these devices treat adult heart attack victims by analyzing the heart rhythm and sending an electrical shock to restore the rhythm.

The company's release said that the recalled AEDs made between March 29, 2007 and August 9, 2007 may fail to analyze or delay in analyzing patient ECG data and may fail to deliver the right therapy. The company noted it received three customer complaints and found defective capacitors manufactured by a vendor. Only devices made between those dates listed are affected by the recall. The company says no adverse affects have resulted.

The company notified customers inside and outside the US and instructs customers to call the company for an exchange unit. Both the FDA and the company advise health care providers and customers to report adverse reactions or problems with the product to the FDA's MedWatch Adverse Event Reporting program.

You can find the FDA's notice concerning the recall here

The company's press release concerning the recall is found here

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