Z-1235-2023Class II

Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial...

Name: Z-1235-2023 Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial...
Creator: Sensus Healthcare, Inc.
Published: 2023-02-10
License: https://open.fda.gov/license/

Sensus Healthcare / initiated 2023-02-10 / Terminated / root cause: software

FDA source

Sensus Healthcare, Inc. began a recall of 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... on 2023-02-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1235-2023
Classification: Class II
Status: Terminated
Initiated: 2023-02-10
Posted: 2023-03-08
Terminated: 2024-01-31
Recalling firm: Sensus Healthcare
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
Product code: JAD System, Therapeutic, X-Ray
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.
Root cause tag: software
FDA root cause: 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 [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1235-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1235-2023	Class II	Terminated	Voluntary: Firm initiated	2023-03-15	2023-03-08

Product code JAD

K150037Class IISensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging CapabilitiesSensus Healthcare / cleared 2015-10-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)