Sensus Healthcare recalls specific models of X-ray therapy systems with software version 1.9.2 that may reset dose timers when paused, risking unexpected radiation exposure during treatment.
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.
Sensus Healthcare is recalling certain X-ray therapy systems that may deliver an unexpected radiation dose to patients when the beam delivery is paused. This could cause unnecessary radiation exposure during treatment.
When the user pauses the beam delivery, the dose timer resets to zero. This can cause the system to deliver an unexpected radiation dose to the patient during treatment, potentially increasing radiation exposure without the user realizing it.
Patients receiving radiation therapy using the recalled SRT-100 Vision IPX 0 models with software version 1.9.2 are most at risk. Healthcare providers using these systems for superficial X-ray treatments should also be cautious.
Check if your SRT-100 Vision IPX 0 system has software version 1.9.2. The serial numbers listed in the recall include 1512-2002 through 2206-2272.
Verify your system's software version by checking the device settings or documentation.
Reach out to Sensus Healthcare for guidance on whether your system is affected and next steps.
Yes, the system may deliver an unexpected radiation dose to patients when the beam delivery is paused, which could increase radiation exposure during treatment.
Check if your SRT-100 Vision IPX 0 system has software version 1.9.2 with serial numbers listed in the recall (1512-2002 through 2206-2272).
Contact Sensus Healthcare for guidance on whether your system is affected and next steps.
We’ve drafted a message you can send Sensus Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1235-2023 — Sensus Healthcare Sensus Healthcare Hello, I own a Sensus Healthcare that is covered by recall Z-1235-2023 from Sensus Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
