Recall Z-1400-2012 ยท DSI Detector And Alarm, Arrhythmia
Scottcare Corporation
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 a
| Date | Apr 13, 2012 (initiated Jan 19, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| 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. |
| Quantity | 513 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of CA, DE, FL, MI, NJ, NV, NY, OH, PA and TX, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092947 | TELESENTRY, MODEL TS01 Scottcare Corporation, Feb 26, 2010 |