The Recall Desk
ModerateFDA (Devices)·Z-0297-2022·Announced 2021-12-01

Siemens Artis zee x-ray system may delay imaging delivery during procedures

Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The issue is a software operational defect causing procedural delays rather than a direct safety hazard with reported adverse events.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Artis zee ceiling-mounted x-ray systems equipped with VD12 software used for diagnostic imaging and interventional procedures. The recall affects 8 units distributed nationwide.

The recalled systems have a software issue: when the source-to-image distance (SID) lift mechanism is activated while x-ray release is simultaneously attempted, the x-ray cannot be delivered. Instead, the system displays a message stating "No x-ray, try again," resulting in a short delay in the procedure.

The recalled product

Product
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Manufacturer
Siemens Medical Solutions USA, Inc
Hazard
  • operational-defect
  • software-malfunction

Distribution

Distributed nationwide across the United States.