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 Radiatio…
- Recall date
- February 10, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1235-2023
- FDA classification
- Class II
- Brand / firm
- Sensus Healthcare, Inc.
- Sold / distributed
- US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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