Date Initiated by Firm |
January 24, 2007 |
Date Posted |
March 31, 2007 |
Recall Status1 |
Terminated 3 on December 12, 2007 |
Recall Number |
Z-0691-2007 |
Recall Event ID |
37291 |
PMA Number |
P000040 |
Product Classification |
Thermal endometrial ablation system - Product Code MNB
|
Product |
HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system) |
Code Information |
Unit Numbers: IN0339JC, IN0340JC, |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation One Boston Scientific Place Natick MA 01760-1536
|
For Additional Information Contact |
Cindy Finney 508-683-4186
|
Manufacturer 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
|
FDA Determined Cause 2 |
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 in Commerce |
2 units |
Distribution |
Worldwide-USA, UK, Denmark, Italy, and France |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
PMA Database |
PMAs with Product Code = MNB and Original Applicant = Minerva Surgical, Inc.
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