Home / Recalls / PROCEPT BIOROBOTICS CORPORATION / Z-1110-2019

Z-1110-2019 Class II Terminated

Recalled by PROCEPT BIOROBOTICS CORPORATION — Redwood City, CA

Recall Details

Product Type: Devices
Report Date: April 17, 2019
Initiation Date: March 6, 2019
Termination Date: November 13, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 214

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.

Distribution Pattern

Worldwide Distribution: US (nationwide) state to: TX, FL, IN, CA, IL, VA, MI, PA.; and (OUS) countries of: Italy, Germany, France, Poland, United Kingdom, Spain, Canada and Australia.

Code Information

Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244. Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234