Reported Mar 15, 2023 · Terminated
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray…
Sensus Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sensus Healthcare, Inc. · 851 Broken Sound Pkwy Nw Ste 215 · Boca Raton, FL · 33487-3635
Is this the product you have?
- 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
- Lot codes and dates
- Software version 1.9.2
- loaded onto Serial Numbers
1512-20021512-20031606-20071609-20101609-20111609-20181612-20231612-20251705-20321709-20461803-20681906-21371909-21491912-21672003-21772112-22012112-22022112-22082112-22182203-22322203-22412206-22642206-2272
- Amount recalled
- 23 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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