FDA recall Z-1235-2023

Product

Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

Reason for recall

When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.

Distribution

US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.

Key facts

Status

Terminated

Initiation date

2023-02-10

Report date

2023-03-15

Termination date

2024-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2023