Siemens ARTIS Pheno X-Ray System Recalled for C-Arm Drop Hazard
Siemens is recalling 39 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because the C-arm may drop up to 20 mm, potentially injuring patients.
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 risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for potential patient injury from a mechanical defect.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 39 units of the ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000. The recall involves specific serial numbers listed in the agency's structured data. The devices were distributed to healthcare facilities in 18 U.S. states and 21 foreign countries.
The recall is due to a safety issue where the C-arm may drop up to 20 mm (0.8 inches) if manually moved to a fully extended position, activating the safety stop mechanism. Under certain circumstances, the detector or collimator cover can touch the patient during this drop, causing injury. This may require stopping clinical treatment or switching to an alternative system.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The source text does not specify a deadline or specific corrective action steps beyond the recall notification.
The recalled product
- Product
- ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 39
Distribution
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