Hasselager, N/A, Denmark
NRT X-RAY A/S recalls
3 recalls recorded since 2018, most recently on 17 April 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 April 2024
- 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.
- Distribution
- US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1784-2024
- Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Ongoing Class II Medical devices
- Recall started
- 27 April 2023
- Reason
- There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
- Distribution
- US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1669-2023, Z-1668-2023
- Intelli-C, Left side suspended Tabletop, REF: 03400010
- Intelli-C, Right side suspended Tabletop, REF: 03400000
Ongoing Class II Medical devices
- Recall started
- 21 January 2022
- Reason
- Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.
- Distribution
- USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0526-2022
- 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.