AED Recalls

Alert Details for #2004110147 (Released 11/10/2004 11:45 EST)
Description: ACCESS AED AND ACCESS ALS AED DEFIBRILLATORS
Manufacturer: ACCESS CARDIO SYS
Reason: THE SHOCK DELIVERY CIRCUIT MAY FAIL. THE FAILURE MODE IS RESTRICTED TO A SPECIFIC BATCH OF ONE DEVICE COMPONENT (SEE LOT).
Analyst Comments: COMPLY WITH MFR INSTRUCTIONS IF RECEIVED. OTHERWISE, IMMEDIATELY DISCONTINUE USE AND REMOVE FROM SERVICE. THE COMPANY HAS DISCONTINUED MANUFACTURING AND MARKETING ALL MODELS OF ITS AEDS AND DISCONTINUED SUPPORTING ITS AEDS THAT ARE CURRENTLY IN THE FIELD. FOR ADDL INFO CALL ACCESS' RECALL COORDINATOR AT 978-405-1057.

Alert Type: Recall Source Alert Type: --
Domain: Biomedical Devices Source Type: US Army Medical Materiel Agency
Distribution:   Source Date: 11/09/2004

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Product Information
Product Description Model/Product Number Stock Identifiers Volume Recall ID
ACCESS AED AND ALS AUTOMATED EXTERNAL DEFIBRILLATOR UPN: 9100-0100 075690 THRU 077140 Not specified MMQC - 04 - 1301
ACCESS AED AND ALS AUTOMATED EXTERNAL DEFIBRILLATOR UPN: 9100-0100 075180 THRU 084760 Not specified MMQC - 04 - 1301