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Sensus Healthcare, Inc. recalls Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation
Recalled March 15, 2023 · FDA recall Z-1235-2023 · Sensus Healthcare
Hazard
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. · FDA Class II
Units
23 units
Sold at
US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
Description
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.
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
Manufacturer(s)
Sensus Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →