LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance

FDA device recall Z-0207-2012 · posted 2011-11-17 · Terminated

Recall details

Recalling firm

Lifewatch Services Inc

Reason for recall

LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DXH

Quantity affected

442 sensors

Distribution

Nationwide distribution.

Date initiated

2011-09-26

Date posted

2011-11-17

Date terminated

2012-05-15

Location

Rosemont, IL

Related 510(k) clearances