AED Recalls

AED Recalls

Alert Details for #2006020329 (Released 2/22/2006 19:34 EST)
Description: Update to RASMAS Alert #2005010242 of 01/18/05 (Expanded Recall by Company) Powerheart AED G3 Automated External Defibrillators Cardiac Science, Inc., Minnetonka, MN 
Manufacturer: Cardiac Science, Inc., Minnetonka, MN 
Reason: AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not function properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is present it will delay the first defibrillation shock in the 3 shock sequence. 
Analyst Comments: Confirm receipt of manufacturer's notice dated February 2, 2006. Follow manufacturer's instructions for correction. Contact: Cardiac Science: Toll Free: +1.888.274.3342 or www.cardiacscience.com

Alert Type: Recall  Source Alert Type: FDA CLASS II
Domain: Biomedical Devices Source Type: FDA Enforcement Report
Distribution: United States, Hungary and Singapore Source Date: 02/22/2006

Links:
http://www.fda.gov/po/enforceindex/2006enforce.html

Product Information
Product Description Model/Product Number Stock Identifiers Volume Recall ID
a) Powerheart AED G3 Automated External Defibrillator.  Model 9300E  a) Serial numbers: 360814 thru 361239, 361320 thru 362359, 362387 thru 362393, 362396 thru 362713, 362916 thru 364194, 364283 thru 364514, and 364606 thru 364914.  Initial recall 2,823 Expanded recall 91.  Z-0398-05
b) Powerheart AED G3 Automated External Defibrillator (Automatic).  Model 9300A b) INITIAL RECALL Model no. 9300A Serial numbers: 361240 thru 361317, 362360 thru 362386, 362394, 362715 thru 362914, 364195 thru 364274, 364555 thru 364594, 364915 thru 365294. EXPANDED RECALL serial numbers 4000002, 4000004, 4000006, 4000007, 4000009, 4000010, 4000011, 4000013, 4000014, 4000016, 4000018, 4000019, 4000021 thru 4000024, 4000030, 4000031, 4000034, 4000040, 4000044, 4000045, 4000047, 4000048, 4000050, 4000051, 4000054, 4000057, 4000060, 4000063, 4000064, 4000065, 4000067, 4000072, 4000075, 4000079, 4000080, 4000082, 4000085, 4000086, 4000089, 4000090, 4000095, 4000097, 4000098, 4000099, 4000136, 4000138, 4000140, 4000145, 4000156, 4000162, 4000164, 4000179, 4000184, 4000186, 4000187, 4000192, 4000209, 4000215, 4000227, 4000229, 4000230, 4000232, 4000247, 4000249, 4000250, 4000255, 4000256, 4000264, 4000271, 4000274, 4000287, 4000288, 4000291, 4000295, 4000305, 4000306, 4000314, 4000322, 4000323, 4000324, 4000326, 4000330 thru 4000335, 4000337, 4000342.  Initial recall 2,823 Expanded recall 91.  Z-0399-05 
(c) Powerheart AED G3 Automated External Defibrillator Professional series.  Model 9300P  (c) Serial numbers: 900290 thru 900870.  Initial recall 2,823 Expanded recall 91.  Z-0400-05