LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel 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; Model FG-00084 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. The ACT III will provide more sensitive data for initial or early detection of arrhythmia in patients that have minimal or atypical symptoms.
Recall
- Recall Number
- Z-0207-2012
- Event Number
- 59990
- Firm
- Lifewatch Services Inc
- FEI Number
- 1000127138
- Product Code
- DXH
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 26, 2011
- Posted
- November 17, 2011
- Terminated
- May 15, 2012
- Address
- 10255 W Higgins Rd, O'Hare International Center II Rosemont, IL, 60018-5606
Description
LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel 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; Model FG-00084 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. The ACT III will provide more sensitive data for initial or early detection of arrhythmia in patients that have minimal or atypical symptoms.
LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
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.
Nationwide distribution.
442 sensors