Sensus Healthcare Inc recall
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…
Why was Sensus Healthcare Inc recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Sensus Healthcare, Inc.
- Quantity
- 23 units
- Distribution
- US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
- Recall date
- March 15, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)