Siemens Artis Q angiography systems may fail to deliver x-ray during procedures
Siemens Artis Q angiography systems may fail to release x-ray when source-to-image distance lift and x-ray release are activated simultaneously, causing procedure delays.
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 a Class II medical device recall with no reported injuries or illnesses. The hazard involves potential failure of x-ray delivery during critical diagnostic and interventional procedures, representing a risk-of-harm scenario in a high-risk medical context.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Artis Q ceiling-mounted angiography systems with software version VD12 used for diagnostic imaging and interventional procedures. The recall addresses a software issue where simultaneous activation of source-to-image distance (SID) lift movement and x-ray release prevents x-ray delivery, causing the system to display a "No x-ray, try again" message and resulting in procedure delays.
This Class II recall affects 67 units distributed nationwide across the United States. The affected systems can be identified by serial numbers listed in the FDA recall notice.
Healthcare facilities currently using Artis Q systems should verify whether their equipment is affected by checking the provided serial numbers. Affected facilities should contact Siemens Medical Solutions USA, Inc. for guidance on resolving this issue.
The recalled product
- Product
- Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- equipment-malfunction
- procedure-delay
Distribution
Distributed nationwide across the United States.
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