Z-0206-2012

LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel...

Name: Z-0206-2012 LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel...
Creator: Lifewatch Services Inc
Published: 2011-09-26
License: https://open.fda.gov/license/

Lifewatch Services, Inc. / initiated 2011-09-26 / Terminated / root cause: manufacturing process

FDA source

Lifewatch Services Inc began a recall of LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel EKG, office hookup and auto send/auto detect that... on 2011-09-26. The reason FDA records is "LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0206-2012
Status: Terminated
Initiated: 2011-09-26
Posted: 2011-11-17
Terminated: 2012-05-15
Recalling firm: Lifewatch Services, Inc.
Product: LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single 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-00065 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.
Product code: DXH Transmitters And Receivers, Electrocardiograph, Telephone
Reason for recall: LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
Root cause tag: manufacturing process
FDA 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 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: 120 sensors
Distribution: Nationwide distribution.
Product codes and lots: Model FG-00065, all serial numbers with firmware REV 01.G

Product code DXH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)