Siemens Fluoroscopic X-ray Systems Risk of Boot Failure After Shutdown
Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.
What this means for you
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 affecting a medical imaging system where potential for treatment disruption represents a risk-of-harm scenario. No injuries or hospitalizations have been reported; the hazard is operational in nature and occurs only in rare cases.
Plain-English summary
Siemens Medical Solutions USA is recalling multiple models of fluoroscopic X-ray systems (Artis zee and Artis Q series) used in clinical settings. The recall affects 609 units in the United States and 1627 units worldwide, identified by specific serial numbers for each model variant.
In rare cases, these systems may only boot into backup mode after an abrupt shutdown and fail to reach full operating mode. This limitation could force healthcare facilities to cancel ongoing clinical treatments or transition patients to alternative imaging systems.
Healthcare facilities operating these specific models should review the affected serial numbers and contact Siemens Medical Solutions USA for further instructions and remediation options.
The recalled product
- Product
- System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 108
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- device-malfunction
- treatment-disruption
Distribution
Distributed nationwide across the United States.
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