PlainRecalls
FDA Devices Moderate Class II Ongoing

Intelli-C, Right side suspended Tabletop, REF: 03400000

Reported: June 7, 2023 Initiated: April 27, 2023 #Z-1668-2023

Product Description

Intelli-C, Right side suspended Tabletop, REF: 03400000

Reason for Recall

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.

Details

Recalling Firm
NRT X-RAY A/S
Units Affected
32 units
Distribution
US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
Location
Hasselager, N/A

Frequently Asked Questions

What product was recalled?
Intelli-C, Right side suspended Tabletop, REF: 03400000. Recalled by NRT X-RAY A/S. Units affected: 32 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 7, 2023. Severity: Moderate. Recall number: Z-1668-2023.