Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sensus Healthcare Inc Recalled by Sensus Healthcare, Inc. Due to When the user pauses the beam delivery, the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sensus Healthcare, Inc. directly.
Affected Products
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
Quantity: 23 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 7 states: FL, IL, IN, IA, NM, NY, NC
About Sensus Healthcare, Inc.
Sensus Healthcare, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report