Company: Welch Allyn Protocol, Inc
Date of Enforcement Report 8/5/2009
Class:ll
PRODUCT
Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively “AED 10”), Recall # Z-1656-2009
REASON
Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to be delayed or interrupted.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Welch Allyn Protocol, Inc., Beaverton, OR, by letter on April 24, 2009.
Manufacturer: MRL, Inc., A Welch Allyn Co., Buffalo Grove, IL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
46,740 units
DISTRIBUTION
Nationwide and internationally
