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U.S. Department of Health and Human Services

Class 2 Device Recall Sensus Healthcare Inc

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  Class 2 Device Recall Sensus Healthcare Inc see related information
Date Initiated by Firm February 10, 2023
Date Posted March 08, 2023
Recall Status1 Terminated 3 on January 31, 2024
Recall Number Z-1235-2023
Recall Event ID 91795
510(K)Number K150037  
Product Classification System, therapeutic, x-ray - Product Code JAD
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 Ultrasonic Imaging Capabilities
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
Recalling Firm/
Manufacturer		 Sensus Healthcare, Inc.
851 Broken Sound Pkwy Nw Ste 215
Boca Raton FL 33487-3635
For Additional Information Contact Sean A. Delaney
408-694-2170
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Sensus healthcare issued an "Urgent Device Correction" to its consignees on 02/10/2023 by email. The notice requested the following actions: "Do not initiate beam delivery after a pause & resume sequence without verifying the amount of dose delivered. Do evaluate any patient treatments with version 1.9.2 that followed the pause & resume workflow. Do verify that the amount of dose to be delivered is as expected after each pause & resume sequence." The firm has developed a permanent software resolution for this issue. Customer service will contact the customer to coordinate upgrading to this revised software. Questions: Contact Sensus Customer Support at support@sensushealthcare.com or 561-578-4982
Quantity in Commerce 23 units
Distribution US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAD and Original Applicant = SENSUS HEALTHCARE
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