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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 67
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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