HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation Unit (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
FDA Recall Z-0689-2007 · Posted 2007-03-31
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeMNB
Date Initiated2007-01-24
Date Terminated2007-12-12
Product Quantity8 units
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
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide-USA, UK, Denmark, Italy, and France
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.