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HYDROS Robotic System
PROCEPT BioRobotics Corporation · Model HY1000 · UDI-DI 00850055427068
9
510(k) clearances
1,449
Adverse events (35 deaths)
2
Recalls
9
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-07-09 | PROCEPT BIOROBOTICS CORPORATION | Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip s |
| 2019-03-06 | PROCEPT BIOROBOTICS CORPORATION | Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device in |
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