Device recall
Z-1110-2019: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of…
FDA device recall · Class II · PROCEPT BIOROBOTICS CORPORATION
Key facts
| Recall number (Z-number) | Z-1110-2019 |
|---|---|
| Recall event | 82462 |
| 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… |
| Product code | PZP |
| Recalling firm | PROCEPT BIOROBOTICS CORPORATION |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 13, 2020 |
| FEI number | 3027788423 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database