Recall Z-1110-2019 ยท PZP Fluid Jet Removal System
PROCEPT BIOROBOTICS CORPORATION
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).
| Date | Mar 6, 2019 |
| Status | Terminated |
| 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. |
| Root cause | 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. O |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.