Recall Z-1315-2016 ยท DSI Detector And Alarm, Arrhythmia
Scottcare Corporation
TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia.
| Date | Feb 25, 2016 |
| Status | Terminated |
| Reason | The firm received a complaint of the battery exploding while recharging. |
| Root cause | Device Design |
| Action | On 2/26/2016 the firm sent "Urgent: TeleSentry Battery Recall" notification letters to their customers. The letter identified the affected device and the reason for the recall. Customers were asked to immediately examine their inventory and quarantine the affected device. If the product had been further distributed, then a copy of the letter should be provided to those customers. Customers are to follow the steps provided for returning the affected device, including contacting ScottCare Service at 1-800-243-9412. In addition, the attached response form should be completed and returned. |
| Quantity | 9,067 batteries |
| Distribution | Worldwide Distribution -- USA, including the states of CA, CT, DE, FL, IL, KS, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, & WV; 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 |