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Device Recall Boston Scientific HTA Thermal endometrial ablation system
Model / Serial
Unit Numbers: IN0335JC, IN0344JE, IN0345JE, IN0349JE, IN0352JG, IN0353JG, IN0355JG, IN0356JG
Product Classification
Obstetrical and Gynecological Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide-USA, UK, Denmark, Italy, and France
Product Description
HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation Unit (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
Manufacturer
Boston Scientific Corporation
1 Event
Recall of Device Recall Boston Scientific HTA Thermal endometrial ablation system
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Manufacturer
Boston Scientific Corporation
Manufacturer Address
Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760-1536
Source
USFDA
Language
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