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U.S. Department of Health and Human Services

Class 1 Device Recall SAMARITAN AED DEFIBRILLATORS

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 Class 1 Device Recall SAMARITAN AED DEFIBRILLATORSsee related information
Date Initiated by FirmFebruary 14, 2005
Date PostedMarch 23, 2005
Recall Status1 Terminated 3 on June 08, 2011
Recall NumberZ-0641-05
Recall Event ID 31212
Product Classification automated external defibrillator - Product Code MKJ
ProductHeartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).
Code Information Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).
Recalling Firm/
Manufacturer		 Heartsine Technologies Inc
940 Calle Amanecer Ste E
San Clemente CA 92673-6218
For Additional Information ContactGeorge C. Brdlik
949-218-0092
Manufacturer Reason
for Recall		The affected Automatic External Defibrillators (AED) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionRecall was initiated by telephone 2/14/2005 with follow-up fax, email or postal mailing using one of several customized letters for distributors or customers. Customers will be sent an upgrade kit by overnite mail and forms to confirm upgrade.
Quantity in Commerce672
DistributionNationwide to distributors and user facilities. Also to Argentina, Austria, Belgium, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Thailand, United Kingdom.
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.
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