Welch Allyn today announced a voluntary worldwide recall of 14,054 AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002 and January 25, 2007.
There is a remote chance that these devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference. If such issues arise, it may prevent defibrillation of a patient in cardiac arrest and could lead to death. There have been 20 reported instances of low energy shock, 8 of electromagnetic noise interference, and 11 of unexpected device shutdown.
Because the chance of malfunction is remote, customers should keep AED 10 or MRL JumpStart units in use until they receive replacements. If a unit gives a low energy shock warning during use, consumers should keep using the device in accordance with its voice prompts and directions for use. A low energy shock may still be clinically effective, and a full energy shock can follow a low energy shock.
Recall notification was sent to U.S. and Canada customers via certified mail sent on February 26 27, 2009. These device owners should contact the Welch Allyn AED 10 Recall Center at 1.888.345.5356 between 8 am and 5 pm EST. Customers may visit http://www.welchallyn.com/AED10Recall for more information or to learn if their unit is subject to this recall. Shipment authorization, pre-paid UPS shipment labels, packing instructions and packaging supplies will be provided free of charge to facilitate device return. All other international customers will be notified of the recall later this month.
U.S. and Canada customers will have two replacement options. They may: (1) at no cost, exchange their Welch Allyn AED 10 for a like device, or (2) purchase a new AED 10 directly from Welch Allyn, with a standard 5-year warranty, at a significantly reduced cost. All international customers will be offered exchange AED 10 devices.
The U.S. Food and Drug Administration (FDA) has been apprised of this action.
Adverse reactions or quality problems with this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 - Fax: 1-800-FDA-0178