FDAFDA · Food and drugs·Recall number Z-0972-2022
Artis zee biplane MN, Model Number 10094143
Published April 27, 2022 · Recall initiated: February 23, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide.
- Lot
- UDI: 4056869010106; Serial Numbers: 149100 149401 149421 149106 149202 149420 149402
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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