HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
- Recall Initiated
- January 24, 2007
- Posted
- March 31, 2007
- Terminated
- December 12, 2007
- Recall Number
- Z-0690-2007
- Quantity
- 2 units
- Firm Location
- Scientific Place Natick, MA
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
Distribution
Worldwide-USA, UK, Denmark, Italy, and France
Lot / Code Info
Unit Numbers: IN0350JG, IN0351JG,
Root 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.
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