Artis Q zeego, Model Number 10848283

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Siemens Medical Solutions USA, Inc
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".
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Artis Q zeego, Model Number 10848283

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0977-2022

Related Recalls

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Class I - Dangerous

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

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During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

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