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U.S. Department of Health and Human Services

Class 2 Device Recall AQUABEAM

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  Class 2 Device Recall AQUABEAM see related information
Date Initiated by Firm March 06, 2019
Create Date April 08, 2019
Recall Status1 Terminated 3 on November 13, 2020
Recall Number Z-1110-2019
Recall Event ID 82462
Product Classification Fluid jet removal system - Product Code PZP
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).
Code Information Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244.  Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234
Recalling Firm/
Manufacturer		 PROCEPT BIOROBOTICS CORPORATION
900 Island Dr Ste 101
Redwood City CA 94065-5176
For Additional Information Contact Mr. Bijesh Chandran
650-232-7203
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action On 03/06/19, the firm, Procept BioRobotics, sent an"URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter via priority overnight mail with delivery confirmation to customers with affected devices. The letter the described the product, problem and actions to be taken. Customers were instructed to discontinue use and segregate affected devices. In addition, customers were asked to pass along the recall notice to all those who need to be aware of it within their organization and to complete and return the Recall Acknowledgement Form via Email: cs@procept-biorobotics.com or Fax to: +1.888.285.3777. Once the firm receives acknowledgement forms listing affected product, the firm will provide instructions on how to return affected product. Customers with questions are encouraged to call customer service at 1-650-232-7222. On 03/06/19, Courtesy Notification: Voluntary Medical Device Recall notices were mailed via priority overnight mail with delivery confirmation to customers who received non-affected devices. Customers who did not receive affected product were advised that no actions needed to be taken. Customers with questions are encouraged to call customer service at 1-650-232-7222. If you have any questions, please feel free to contact your local Aquablation Consultant or PROCEPT Customer Service by telephone at +1.650.232.7222 or email cs@procept-biorobotics.com.
Quantity in Commerce 214
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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