The Recall Desk
ModerateFDA (Devices)·Z-0298-2022·Announced 2021-12-01

Siemens Artis Zee Angiography System Software May Prevent X-Ray Activation

Siemens is recalling 19 units of its Artis zee angiography system due to a software issue that may prevent x-ray activation under specific operating conditions, causing procedural delay.

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: Class II recall with no reported injuries or illnesses. The software malfunction causes a procedural delay rather than direct patient harm, meeting the criteria for Moderate severity.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 19 units of the Artis zee multi-purpose angiography system with software version VD12 used for diagnostic imaging and interventional procedures. The recalled units have specific serial numbers and were distributed across the United States.

The recalled systems have a software issue that may prevent x-ray activation when the source-to-image distance (SID) lift movement is activated and an x-ray is simultaneously requested. When this occurs, the system displays an error message stating "No x-ray, try again" and the x-ray cannot be generated, resulting in a short delay during the procedure.

Siemens Medical Solutions has implemented a correction for this issue. Healthcare facilities that own or operate one of the recalled systems should contact Siemens Medical Solutions USA, Inc. directly for guidance on obtaining the software update.

The recalled product

Product
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
Manufacturer
Siemens Medical Solutions USA, Inc
Hazard
  • software-malfunction
  • procedure-delay

Distribution

Distributed nationwide across the United States.