Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation
FDA device recall Z-1235-2023 · posted 2023-03-08 · Terminated
Recall details
- Recalling firm
- Sensus Healthcare, Inc.
- 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.
- Action taken
- 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 revised software. Questions: Contact Sensus Customer Support at support@sensushealthcare.com or 561-578-4982
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAD
- Quantity affected
- 23 units
- Distribution
- US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
- Date initiated
- 2023-02-10
- Date posted
- 2023-03-08
- Date terminated
- 2024-01-31
- Location
- Boca Raton, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (K150037) | Sensus Healthcare | 2015-10-16 |