The Recall Desk
HighFDA (Devices)·Z-0977-2022·Announced 2022-04-27

Artis Q zeego X-ray system recalled for inadequate cooling risk

Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic system shutdown.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm scenario where inadequate cooling could compromise equipment operation. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3). No illnesses or injuries are reported in the source.

Plain-English summary

Siemens Medical Solutions USA, Inc is recalling 38 Artis Q zeego X-ray imaging systems (Model Number 10848283) due to a cooling circuit malfunction. The systems are distributed nationwide.

If the coolant level in the cooling circuit drops below a certain level, the X-ray tube may not be sufficiently cooled. The system will initially display the message 'TUBE HOT, have a break'. Several minutes later, the system will block X-ray operation and display 'NO XRAY: TUBE TOO HOT' to prevent further equipment damage.

Users of affected systems should contact Siemens Medical Solutions USA, Inc for information on remediation. Affected serial numbers and the device UDI (4056869010007) are identified in the recall notice.

The recalled product

Product
Artis Q zeego, Model Number 10848283
Manufacturer
Siemens Medical Solutions USA, Inc
Hazard
  • inadequate-cooling
  • equipment-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI: 4056869010007

Distribution

Distributed nationwide across the United States.