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
___________________________________
