Collision Sensor Malfunction in Siemens ARTIS Icono Fluoroscopic X-Ray System
The ARTIS icono fluoroscopic x-ray system may falsely detect collisions for up to 30 minutes after startup, requiring manual override with reduced safety protection and limiting diagnostic use.
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 an FDA Class II recall involving a risk-of-harm medical device with no reported injuries. The collision sensor malfunction creates a potential safety risk during manual override operations, but no hospitalizations or injuries have been documented, supporting a High severity score.
Plain-English summary
The Siemens ARTIS icono ceiling-mounted fluoroscopic x-ray system (Model 11328100) is subject to recall due to a collision sensor malfunction. The sensor may falsely indicate the presence of collisions for up to 30 minutes when the system is switched off for extended periods (such as overnight) and then restarted.
When false collision signals occur, the system can only be moved using the manual override function, which operates at very low speed and without the normal collision protection safeguards. This results in temporary unavailability of the equipment for diagnostic and therapeutic procedures.
The recall affects 38 units worldwide, including 11 in the United States. The product has been distributed to facilities in Florida, Georgia, Iowa, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, Pennsylvania, and Texas, as well as internationally to Australia, Canada, Switzerland, China, Germany, Denmark, Egypt, Spain, Finland, the United Kingdom, Israel, the Netherlands, Sweden, and South Africa.
Healthcare facilities using the ARTIS icono should contact Siemens Medical Solutions USA, Inc. for technical guidance and remediation. No injuries or illnesses have been reported in association with this malfunction.
The recalled product
- Product
- ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
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