Home / Recalls / NRT X-RAY A/S / Z-1784-2024

Z-1784-2024 Class II Ongoing

Recalled by NRT X-RAY A/S — Hasselager, N/A

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