, Class II Boston Scientific Corp.

Company:Boston Scientific Corp.
Date of Enforcement Report:4/6/2007
Class:ll

PRODUCT
a) Product Description: HTA Console System, 110 Volt, Product Number: 56000
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), Recall # Z-0687-2007;
b) HTA Console System, 230 Volt, English, Product Number: 560010
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), Recall # Z-0688-2007;
c) 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 # Z-0689-2007;
d) HTA Console System, 230 Volt , French, Product Number: 56001FO
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), Recall # Z-0690-2007;
e) HTA Console System, 230 Volt , Italian, Product Number: 56001 IO
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), Recall # Z-0691-2007;

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.

CODE
a) 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;
b) Unit Numbers: IN0335JC, IN0337JC, IN0341JD, IN0342JD, IN0343JD,
IN0344JE, IN0345JE, IN0347JE, IN0348JE, IN0349JE, IN0352JG,
IN0353JG, IN0355JG, IN0356JG;
c) Unit Numbers: IN0335JC, IN0344JE, IN0345JE, IN0349JE, IN0352JG,
IN0353JG, IN0355JG, IN0356JG;
d) Unit Numbers: IN0350JG, IN0351JG;
e) Unit Numbers: IN0339JC, IN0340JC

RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA., by letter dated January 24, 2007.
Manufacturer: Nexcore Technology, Inc., Waldrick, NJ. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
51 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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