Siemens Artis Zee Biplane X-ray Imaging System Software Malfunction
Siemens Artis zee biplane X-ray imaging systems may fail to release X-rays when the source-to-image distance lift is activated simultaneously, 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 device with no reported injuries, deaths, or hospitalizations. The hazard is a procedural delay due to system malfunction when specific operational conditions occur simultaneously, not a direct patient safety risk.
Plain-English summary
The U.S. Food and Drug Administration has identified a software malfunction in Siemens Artis zee biplane X-ray imaging systems with model number 10094141. When the source-to-image distance (SID) lift movement is activated at the same time an X-ray is commanded to release, the system cannot generate the X-ray image. Instead, it displays the message "No X-ray, try again."
This malfunction affects 2 units (serial numbers 156011 and 156014) distributed nationwide in the United States. The failure results in a short delay to the imaging procedure while operators reactivate the system and retry the imaging sequence.
No injuries or harm have been reported related to this malfunction. Affected medical facilities should contact Siemens Medical Solutions USA, Inc. for additional guidance or a software update to correct the issue.
The recalled product
- Product
- Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- imaging-failure
- device-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)
- Serial Numbers: 156011 156014
Distribution
Distributed nationwide across the United States.
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