Siemens Artis Q.zen Angiography System X-Ray Imaging Delay Issue
Siemens has recalled two Artis Q.zen angiography systems due to a software issue that may prevent x-ray imaging and delay procedures when SID lift and x-ray controls are activated simultaneously.
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: This FDA Class II recall involves a software-related operational issue in diagnostic imaging equipment. The hazard results in a temporary imaging failure and procedure delay but does not involve reported injuries, illnesses, or direct threats to patient safety.
Plain-English summary
Siemens Medical Solutions USA, Inc. has recalled two Artis Q.zen biplane angiography systems with software version VD12 (Model Number 10848355). These systems are designed for diagnostic imaging and interventional medical procedures.
The recall addresses a software issue where simultaneous activation of the source-to-image distance (SID) lift movement and x-ray release causes the x-ray function to fail. When this condition occurs, the system displays an error message stating "No x-ray, try again" and the procedure experiences a short delay.
The two affected units with serial numbers 123502 and 123501 have been distributed nationwide in the United States.
The recalled product
- Product
- Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 2
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: 123502 123501
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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