Recall Z-0691-2007 ยท MNB Device, Thermal Ablation, Endometrial
Boston Scientific Corporation
HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
| Date | Mar 31, 2007 (initiated Jan 24, 2007) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Other |
| Action | Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product. |
| Quantity | 2 units |
| Distribution | Worldwide-USA, UK, Denmark, Italy, and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.