Reported Apr 17, 2019 · Terminated
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301…
Procept Biorobotics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PROCEPT BIOROBOTICS CORPORATION · 900 Island Dr Ste 101 · Redwood City, CA · 94065-5176
Is this the product you have?
- AquaBeam Handpiece, Sterile EO, Rx Only
- REF310301, 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)
- Lot codes and dates
- Domestic Lots
18C0068118C0077018C0085218C01244
- Foreign Lots
18C0079918C0084418C0098518C0102418C0104418C01234
- Domestic Lots
- Amount recalled
- 214
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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