Z-1784-2024 Class II Ongoing
FDA device recall Z-1784-2024 was initiated by NRT X-RAY A/S on April 17, 2024 and is designated Class II. 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 angula… The recall status is ongoing. Affected quantity: 35.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2024
- Initiation Date
- April 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
Product Description
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
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.
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.
Code Information
REF/UDI-DI/Serial Numbers: 03400000/05713464000527/627002, 627004, 627007, 639001, 639002, 639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010, 682011, 696003, 696004, 696006, 696007, 696012. 03400010/05713464000121/647009, 651002, 651006, 666009, 682003, 682023