Siemens ARTIS Pheno-Interventional Fluoroscopic X-Ray System Recalled for Robotic Stand Defect
Siemens Medical Solutions is recalling 96 ARTIS Pheno-Interventional Fluoroscopic X-Ray Systems because safety brakes may block the robotic stand, preventing intended movements.
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: The recall involves a medical device with a mechanical defect that prevents intended movement, representing a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 96 units of the ARTIS Pheno-Interventional Fluoroscopic X-Ray System, Model Number 10849000. The recall affects all serial numbers of this specific model, which were distributed nationwide in the United States.
The recall was initiated because there is a potential for one or more axes of the robotic stand to become blocked by their safety brakes. If an axis is blocked by its safety brake, the robotic stand can no longer perform its intended movements. The source text does not report any injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the issue. The source text does not provide specific contact details or a deadline for action.
The recalled product
- Product
- ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 96
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)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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