FDA recall Z-1784-2024

NRT X-RAY A/S · Class II · device

Product

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

US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI.

Key facts

Status
Ongoing
Initiation date
2024-04-17
Report date
2024-05-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hasselager, N/A, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1784-2024