Recall Z-0207-2012 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
Lifewatch Services Inc
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 info
| Date | Nov 17, 2011 (initiated Sep 26, 2011) |
| Status | Terminated |
| Reason | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| Root cause | 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 |
| Quantity | 442 sensors |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |