Recall Atlas
Drugs & medicalClass II

Sensus Healthcare, Inc. recalls Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System…

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.

Read the official notice →
Date
2023-03-15
Country
United States
Brand
Sensus Healthcare, Inc.
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…
Classification
Class II
Units
US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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