# FDA recall Z-1110-2019

> **PROCEPT BIOROBOTICS CORPORATION** · Class II · device recall initiated 2019-03-06.

## 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 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

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.

## Key facts

- **Recall number:** Z-1110-2019
- **Recalling firm:** PROCEPT BIOROBOTICS CORPORATION
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-06
- **Report date:** 2019-04-17
- **Termination date:** 2020-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redwood City, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1110-2019

## Citation

> AI Analytics. FDA recall Z-1110-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1110-2019. Source: US FDA. Licensed CC0.

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