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
