Recall Z-1235-2023 ยท JAD System, Therapeutic, X-Ray
Sensus Healthcare, Inc.
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
| Date | Mar 8, 2023 (initiated Feb 10, 2023) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Sensus healthcare issued an "Urgent Device Correction" to its consignees on 02/10/2023 by email. The notice requested the following actions: "Do not initiate beam delivery after a pause & resume sequence without verifying the amount of dose delivered. Do evaluate any patient treatments with version 1.9.2 that followed the pause & resume workflow. Do verify that the amount of dose to be delivered is as expected after each pause & resume sequence." The firm has developed a permanent software resolution for this issue. Customer service will contact the customer to coordinate upgrading to this |
| Quantity | 23 units |
| Distribution | US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities Sensus Healthcare, Oct 16, 2015 |