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Genesys HTA System
BOSTON SCIENTIFIC CORPORATION · Model M00658001R0 · UDI-DI 08714729809357
MNB
Prescription
0
510(k) clearances
6,312
Adverse events (22 deaths)
12
Recalls
18
Facilities
Description
Genesys HTA System Control Unit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-20 | Channel Medsystems, Inc. | Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of th |
| 2024-05-03 | Channel Medsystems, Inc. | Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes). |
| 2014-01-24 | Hologic, Inc | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, |
| 2009-07-31 | Boston Scientific Corporation | Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns. |
| 2009-07-31 | Boston Scientific Corporation | Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns. |
| 2007-01-24 | Boston Scientific Corporation | 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 o |
| 2007-01-24 | Boston Scientific Corporation | 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 o |
| 2007-01-24 | Boston Scientific Corporation | 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 o |
| 2007-01-24 | Boston Scientific Corporation | 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 o |
| 2007-01-24 | Boston Scientific Corporation | 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 o |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.