FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation Unit (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
- Recall number
- Z-0689-2007
- Recalling firm
- Boston Scientific Corporation
- Product
- HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation Unit (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
- Status
- Terminated
- Initiated
- 2007-01-24
- Posted
- 2007-03-31
- Terminated
- 2007-12-12
- 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
- 8 units
- Distribution
- Worldwide-USA, UK, Denmark, Italy, and France
- Lot, serial or model codes
- Unit Numbers: IN0335JC, IN0344JE, IN0345JE, IN0349JE, IN0352JG, IN0353JG, IN0355JG, IN0356JG
- 510(k) numbers
- not on file
- PMA numbers
- ["P000040"]
- Product code
- MNB
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28