NRT X-RAY A/S: Device Recall
Recall #Z-1784-2024 · 04/17/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1784-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- NRT X-RAY A/S
- Status
- Ongoing
- Date Initiated
- 04/17/2024
- Location
- Hasselager, N/A, Denmark
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
Reason for Recall
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.
Product Description
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Distribution Pattern
US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.