Z-1110-2019 Class II Terminated
FDA device recall Z-1110-2019 was initiated by PROCEPT BIOROBOTICS CORPORATION on March 6, 2019 and is designated Class II. 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 notifie… The recall status is terminated (terminated November 13, 2020). Affected quantity: 214.
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