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 | |
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