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Siemens Medical Solutions USA, Inc Recall 89860

Description: Artis zee biplane MN, Model Number 10094143

Siemens Medical Solutions USA, Inc Recall 89860 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0972-2022
Event ID89860
Event DescriptionArtis zee biplane MN, Model Number 10094143
Product TypeDevices
DistributionUS Nationwide.
Quantity7 systems
Recall ReasonIf 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".
Device Classification20220427
Device Code InfoUDI: 4056869010106; Serial Numbers: 149100 149401 149421 149106 149202 149420 149402
Center Classification Date20220421
Recall Initiation Date20220223
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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