Siemens ARTIS pheno X-Ray System Recalled for Potential Collision Sensor Blockage
Siemens is recalling six ARTIS pheno X-ray systems because a collision sensor may falsely activate, permanently blocking system movement.
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 is classified as FDA Class II, and the hazard involves a risk of harm (system blockage) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling six units of the Siemens ARTIS pheno Interventional Fluoroscopic X-Ray System, Model # 10849000. The affected serial numbers are 164231, 164234, 164240, 164241, 164242, and 164244. These systems are used for angiography and interventional procedures, including for pediatric and obese patients.
The recall is due to a potential defect where the collision sensor integrated in the cover of the collimator may activate even when no collision has occurred. If this happens, the system movement can be permanently blocked. This is classified as an FDA Class II recall.
The affected units were distributed nationwide in Florida, Illinois, Indiana, Massachusetts, Pennsylvania, and Virginia. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue.
The recalled product
- Product
- Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 6
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 (6)
- Serial Numbers 164231
- 164234
- 164240
- 164241
- 164242
- 164244
Distribution
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