PlainRecalls
FDA Devices Moderate Class II Ongoing

Artis Q.zen floor, Model Number 10848353

Reported: April 27, 2022 Initiated: February 23, 2022 #Z-0978-2022

Product Description

Artis Q.zen floor, Model Number 10848353

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".

Details

Units Affected
33 systems
Distribution
US Nationwide.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis Q.zen floor, Model Number 10848353. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 33 systems.
Why was this product recalled?
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".
Which agency issued this recall?
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0978-2022.