FDAFDA · Food and drugs·Recall number Z-0977-2022
Artis Q zeego, Model Number 10848283
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: 4056869010007; Serial Numbers: 117021 117136 117324 117108 117001 117023 117329 117315 117125 117006 117312 117124 117129 117112 117034 117026 117029 117123 117100 117307 117117 117111 117304 117024 117325 117303 117030 117314 117309 117113 117322 117014 117040 117041 117114 117009 Additional Serial Numbers as of 10/4/23: 117127 117310
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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