Recall Z-1235-2023— Sensus Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Sensus Healthcare, Inc., initiated 2023-02-10, terminated 2024-01-31. It names one FDA 510(k) clearance: K150037. 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. 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..
- Recalling firm
- Sensus Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2023-02-10
- Terminated
- 2024-01-31
- Firm location
- Boca Raton, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.