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U.S. Department of Health and Human Services

Class 2 Device Recall ACT Cellular Phone Monitor

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  Class 2 Device Recall ACT Cellular Phone Monitor see related information
Date Initiated by Firm September 26, 2011
Date Posted November 17, 2011
Recall Status1 Terminated 3 on May 15, 2012
Recall Number Z-0208-2012
Recall Event ID 59990
510(K)Number K071995  K101639  K081257  K110499  
Product Classification Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
Product ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Manufactured by Card Guard, 2 Pekeris St, Rehovot, 76100, Israel; there are two models used with either the ACT 1 sensor or the ACT III sensor:
a) Model Ozone-HTC
b) Model BlackJack2 SGH-i617

LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service.
Code Information Models Ozone-HTC and BlackJack2 SGH-i617, all serial numbers with software version 5.5.9
Recalling Firm/
Manufacturer		 Lifewatch Services Inc
10255 W Higgins Rd
O'Hare International Center II
Rosemont IL 60018-5606
For Additional Information Contact
847-459-7799
Manufacturer Reason
for Recall		 LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, LifeWatch, sent an " Urgent Device Recall" letter dated September 27, 2011 to the affected customers. The letter describes the product, problem and action to be taken. The customers were instructed to immediately refrain from providing these devices to their customers; stop using the affected sensors, return their entire kit in the pre-paid mailer, and use the new device kit included with the recall letter. In addition, the letter informed the users that the replacement device has upgraded software and firmware that allows for detection of shorts in the cable, and if detected, cuts off current flow to the patient to prevent minor shocks and burns. If you have any questions, please call (847) 813-4258.
Quantity in Commerce 532 phone monitors
Distribution Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DXH and Original Applicant = CARD GUARD SCIENTIFIC SURVIVAL LTD.
510(K)s with Product Code = DXH and Original Applicant = CARD GUARD SCIENTIFIC SURVIVAL, LTD.
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