Boca Raton, FL, United States
Sensus Healthcare, Inc. recalls
1 recall recorded since 2018, most recently on 10 February 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 February 2023
- Terminated
- 31 January 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1235-2023
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.