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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Thermal endometrial ablation system

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  Class 2 Device Recall Boston Scientific Thermal endometrial ablation system see related information
Date Initiated by Firm January 24, 2007
Date Posted March 31, 2007
Recall Status1 Terminated 3 on December 12, 2007
Recall Number Z-0687-2007
Recall Event ID 37291
PMA Number P000040 
Product Classification Thermal endometrial ablation system - Product Code MNB
Product HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
Code Information Unit Numbers: N1190JC, N1191JC, N1192JC, N1194JC, N1197JC, N1199JC, N1200JC, N1201JC, N1203JC, N1204JC, N1205JC, N1206JC, N1208JC, N1210JC, N1211JC, N1214JC, N1215JC, N1217JC, N1218JC, N1220JC, N1222JC, N1226JC, N1227JC, N1229JC, N1230JC, N1231JC, N1232JC, N1233JC, N1234JC, N1235JC, N1237JC, N1238JK, N1239JF, N1240JF, N1241JF, N1242JF, N1243JF, N1245JF, N1247JF, N1251JF, N1252JF, N1253JF, N1254JF, N1255JF, N1257JF, N1258JF, N1259JF, N1261JF, N1262JF, N1263JF, N1264JF, N1266JF, N1267JF, N1268JF, N1269JF, N1294JI, N1295JI,
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 57 units
Distribution Worldwide-USA, UK, Denmark, Italy, and France
Total Product Life Cycle TPLC Device Report
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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