TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland, OH. 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.
FDA Recall Z-1400-2012 · Posted 2012-04-13
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Recalling FirmScottcare Corporation
Recall StatusTerminated
Product CodeDSI
Date Initiated2012-01-19
Date Terminated2013-09-27
Product Quantity513 units
Reason for Recall
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.
Firm Action
ScottCare sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 19, 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to immediately discontinue use and quarantine any affected products. A Recall Acknowledgement Form was enclosed for customers to complete and return via fax to (216) 257-6129. Contact the firm at (216) 362-0550 ext. 113 for questions regarding this recall.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of CA, DE, FL, MI, NJ, NV, NY, OH, PA and TX, and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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