Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation
Summary
The FDA issued a Class II for Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software ve by Sensus Healthcare, Inc.. 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..
Details
Source
Device Recall
External ID
Z-1235-2023
Action Date
2023-03-15
Status
Terminated
Category
device
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
Lot/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
Quantity Affected: 23 units
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
US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-10
Company
Boca Raton, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sensus Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sensus Healthcare, Inc. have FDA actions?
This is the only FDA action we have on record for Sensus Healthcare, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1235-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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