FDA recall Z-0975-2022

Product

Artis Q ceiling, Model Number 10848281

Reason for recall

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2022-02-23

Report date

2022-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0975-2022