Radiation Therapy System Software Issue May Cause Unexpected Dose
Sensus Healthcare recalls 23 units of the SRT-100 Vision superficial X-ray radiation therapy system due to a software dose timer malfunction that may result in unexpected radiation delivery to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a medical device Class II recall involving a software malfunction in a radiation therapy system that could deliver unexpected radiation doses to patients. While no illnesses or injuries have been reported, the product presents a clear risk of harm. The software defect addresses an actual device malfunction, not a theoretical hazard.
Plain-English summary
Sensus Healthcare, Inc. is recalling 23 units of the SRT-100 Vision IPX 0 superficial X-ray radiation therapy system with software version 1.9.2. These medical devices are designed to deliver targeted radiation therapy combined with ultrasonic imaging for treating superficial skin conditions.
The recall addresses a software defect in the dose timer. When a physician pauses the X-ray beam delivery, the dose timer resets to zero instead of pausing. This malfunction may result in an unexpected dose of radiation being delivered to the patient if the beam is resumed without accounting for the timer reset.
Twenty-three units with the affected software version have been distributed to medical facilities in nine US states. Each affected device is identified by a specific serial number listed in the FDA recall notice.
Healthcare facilities with affected equipment should contact Sensus Healthcare, Inc. immediately for guidance on this matter.
The recalled product
- 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
- Manufacturer
- Sensus Healthcare, Inc.
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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