FDA recall Z-1668-2023

Product

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.

Distribution

US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.

Key facts

Status

Ongoing

Initiation date

2023-04-27

Report date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hasselager, N/A, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1668-2023