NRT X-RAY A/S 2024-05-15 Health serious FDA
Health · FDA · Recall #FDA-Z-1784-2024
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop,… Recall
Issued May 15, 2024 · NRT X-RAY A/S
In May 2024, NRT X-RAY A/S recalled the Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
What you should do
- 1 Stop using Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact NRT X-RAY A/S 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
- NRT X-RAY A/S
- Category
- Health
- Recall date
- May 15, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI.
- Recall number
- FDA-Z-1784-2024
- Made in
- Denmark
- Issuing agency
- FDA
In context
- NRT X-RAY A/S has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.