HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometri
FDA device recall Z-0687-2007 · posted 2007-03-31 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MNB
- Quantity affected
- 57 units
- Distribution
- Worldwide-USA, UK, Denmark, Italy, and France
- Date initiated
- 2007-01-24
- Date posted
- 2007-03-31
- Date terminated
- 2007-12-12
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.