Reported May 15, 2024 · Ongoing
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the…
Nrt X-Ray A/s
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NRT X-RAY A/S · Birkegardsvej 16 · Hasselager, N/A · N/A
Is this the product you have?
- Intelli-CRight side suspended Tabletop
- REF03400000; Left side suspended Tabletop
- REF03400010, used with the Intelli-C X-ray system
- Lot codes and dates
- REF/UDI-DI/Serial Numbers
03400000/05713464000527/627002627004627007639001639002639003639004639007639010647001647004647005648001651007658002658003658006658010666008675001675004682006682010682011696003696004696006696007696012. 03400010/05713464000121/647009651002651006666009682003682023
- REF/UDI-DI/Serial Numbers
- Amount recalled
- 35
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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