Sensus Healthcare, Inc. 2023-03-15 Health serious FDA
Health · FDA · Recall #FDA-Z-1235-2023
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version… Recall
Issued March 15, 2023 · Sensus Healthcare, Inc.
In March 2023, Sensus Healthcare, Inc. recalled the Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Sensus Healthcare, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Sensus Healthcare, Inc.
- Category
- Health
- Recall date
- March 15, 2023
- Units affected
- Not reported
- Sold at
- US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
- Recall number
- FDA-Z-1235-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Sensus Healthcare, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.