04

May

2012

Cl ll TeleSentry Ambulatory Telemetry

0

Company:Scottcare Corp.
Date of Enforcement Report 5/2/12
Class ll:

PRODUCT
TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01, Part #101086. The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician. Recall # Z-1400-2012

REASON
Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card. The TeleSentry Device then stops functioning.

RECALLING FIRM/MANUFACTURER
Scottcare Corp., Cleveland, OH, by letter dated January 19, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
513 units

DISTRIBUTION
Nationwide and Canada

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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