Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the
FDA device recall Z-0101-2015 · posted 2014-10-21 · Terminated
Recall details
- Recalling firm
- Estill Medical Technologies, Inc
- Reason for recall
- Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes. In addition, the charging voltage range of 10-36V specified on the Ultra Battery 1 (TA-UB1) label and in t
- Action taken
- Thermal Angel sent a Notice of Corrections letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to communicate the contents of the notice to all employees, consignees, consultants, or other parties affected by this correction. The firm also updated the labeling and instructions for use. For additional information cusotmers were instructed to contact Medical Technologies at (877)354-0286.The recalling firm issued a Notice of Corrections to its distributors and customers. For questions regarding this recall call 214-561-6001.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- BSB
- Quantity affected
- 6,886
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Serbia.
- Date initiated
- 2014-07-25
- Date posted
- 2014-10-21
- Date terminated
- 2015-08-21
- Location
- Dallas, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO THERMAL ANGEL (K012031) | Estill Medical Technologies, Inc. | 2001-07-26 |
| THERMAL ANGEL (K984640) | Estill Medical Technologies, Inc. | 1999-07-01 |