HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
- Recall Initiated
- January 24, 2007
- Posted
- March 31, 2007
- Terminated
- December 12, 2007
- Recall Number
- Z-0687-2007
- Quantity
- 57 units
- Firm Location
- Scientific Place Natick, MA
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
Distribution
Worldwide-USA, UK, Denmark, Italy, and France
Lot / Code Info
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,
Root Cause
Other
Action Taken
Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product.