Recall Z-1110-2019— PROCEPT BIOROBOTICS CORPORATION
Class II · Terminated
Class II FDA medical device recall by PROCEPT BIOROBOTICS CORPORATION, initiated 2019-03-06, terminated 2020-11-13. FDA's recall record names no specific 510(k) clearance for this event. Product: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).. Reason: 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 inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure..
- Recalling firm
- PROCEPT BIOROBOTICS CORPORATION
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-06
- Terminated
- 2020-11-13
- Firm location
- Redwood City, CA, United States
Product description
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).
Reason for recall
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 inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.