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
Reported: March 15, 2023 Initiated: February 10, 2023 #Z-1235-2023
Product Description
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.
Details
- Recalling Firm
- Sensus Healthcare, Inc.
- Units Affected
- 23 units
- Distribution
- US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
- Location
- Boca Raton, FL
Frequently Asked Questions
What product 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. Recalled by Sensus Healthcare, Inc.. Units affected: 23 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2023. Severity: Moderate. Recall number: Z-1235-2023.
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