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Siemens Medical Solutions USA, Inc recalls Artis Q.zen floor, Model Number 10848353
Recalled April 27, 2022 · FDA recall Z-0978-2022 · Siemens Medical Solutions USA
Hazard
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". · FDA Class II
Units
33 systems
Sold at
US Nationwide.
Description
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".
Product
Artis Q.zen floor, Model Number 10848353
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →