Recall Z-0688-2007
Boston Scientific Corporation · initiated January 24, 2007
Product
HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
Codes / lots: Unit Numbers: IN0335JC, IN0337JC, IN0341JD, IN0342JD, IN0343JD, IN0344JE, IN0345JE, IN0347JE, IN0348JE, IN0349JE, IN0352JG, IN0353JG, IN0355JG, IN0356JG
Reason for recall
Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment
FDA-determined cause: Other
Action taken
Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product.
Details
- Recall number
- Z-0688-2007
- Initiated
- January 24, 2007
- Posted by FDA
- March 31, 2007
- Terminated
- December 12, 2007
- Product code
- MNB – Device, Thermal Ablation, Endometrial
- Quantity
- 14 units
- Distribution
- Worldwide-USA, UK, Denmark, Italy, and France
- Recalling firm
- Boston Scientific Corporation, Natick, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0687-2007 | HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled…Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90… | 01/24/2007Terminated |
| Z-0689-2007 | HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation…Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90… | 01/24/2007Terminated |
| Z-0690-2007 | HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a…Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90… | 01/24/2007Terminated |
| Z-0691-2007 | HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a…Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90… | 01/24/2007Terminated |