Z-1235-2023 Class II Terminated
FDA device recall Z-1235-2023 was initiated by Sensus Healthcare, Inc. on February 10, 2023 and is designated Class II. 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. The recall status is terminated (terminated January 31, 2024). Affected quantity: 23 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- February 10, 2023
- Termination Date
- January 31, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units
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.
Distribution Pattern
US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
Code Information
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