Sensus Healthcare, Inc. Recall 91795
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
Sensus Healthcare, Inc. Recall 91795 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1235-2023 |
| Event ID | 91795 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL. |
| Quantity | 23 units |
| Recall 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. |
| Device Classification | 20230315 |
| Device Code Info | Software version 1.9.2 loaded onto Serial Numbers: 1512-2002; 1512-2003; 1606-2007; 1609-2010; 1609-2011; 1609-2018; 1612-2023; 1612-2025; 1705-2032; 1709-2046; 1803-2068; 1906-2137; 1909-2149; 1912-2167; 2003-2177; 2112-2201; 2112-2202; 2112-2208; 2112-2218; 2203-2232; 2203-2241; 2206-2264; 2206-2272 |
| Center Classification Date | 20230308 |
| Recall Initiation Date | 20230210 |
| Recalling Firm | Sensus Healthcare, Inc. |
| Initial Notification | |
| Similar To |