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U.S. Department of Health and Human Services

Class 2 Device Recall HeartSine Samaritan AED

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 Class 2 Device Recall HeartSine Samaritan AEDsee related information
Date Initiated by FirmOctober 05, 2005
Date PostedJuly 28, 2005
Recall Status1 Terminated 3 on February 29, 2012
Recall NumberZ-1046-05
Recall Event ID 31445
510(K)NumberK023854 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
ProductHeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.
Code Information Serial numbers within range of 0000101 and 00003986
Recalling Firm/
Manufacturer		 Heartsine Technologies Inc
940 Calle Amanecer Ste E
San Clemente CA 92673-6218
For Additional Information ContactGeroge Brdlik
949-218-0092
Manufacturer Reason
for Recall		Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition.
FDA Determined
Cause 2		Device Design
ActionAED software revision 1.0.20 and higher incorporate software enhancements to make the AED more forgiving for extreme variations in user technique. Firm will provide distributors with field correction notice dated 10/5/05. Customers to be notified by mid-October 2005.
Quantity in Commerce1929 units
DistributionNationwide, Puerto Rico, Argentina, Australia, Austria, Belgium, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Netherlands, Pakistan, Phillipines, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, UK
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MKJ
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