Recall Z-1784-2024— NRT X-RAY A/S

Name: FDA recall Z-1784-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-17

Class II · Ongoing

Class II FDA medical device recall by NRT X-RAY A/S, initiated 2024-04-17. It names one FDA 510(k) clearance: K173631. Product: Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system. Reason: 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..

Recalling firm: NRT X-RAY A/S
Classification: Class II
Status: Ongoing
Initiated: 2024-04-17
Firm location: Hasselager, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K173631 — Intelli-CNrt X-Ray A/S·cleared 2018-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.