PlainRecalls
FDA Devices Moderate Class II Ongoing

Artis zee biplane MN, Model Number 10094143

Reported: April 27, 2022 Initiated: February 23, 2022 #Z-0972-2022

Product Description

Artis zee biplane MN, Model Number 10094143

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
7 systems
Distribution
US Nationwide.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis zee biplane MN, Model Number 10094143. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 7 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-0972-2022.