TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland, OH. The TeleS
FDA device recall Z-1400-2012 · posted 2012-04-13 · Terminated
Recall details
- Recalling firm
- Scottcare Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 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.
- Date initiated
- 2012-01-19
- Date posted
- 2012-04-13
- Date terminated
- 2013-09-27
- Location
- Cleveland, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TELESENTRY, MODEL TS01 (K092947) | Scottcare Corporation | 2010-02-26 |