ARTIS Icono systems may display zero dose while dose is applied
ARTIS Icono interventional fluoroscopic X-ray systems are being recalled because they may sporadically display a zero X-ray dose even though an actual dose is applied to the patient.
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: FDA Class II recall where delivered radiation dose is under-reported as zero, so accumulated exposure may go untracked, a risk of harm with no injuries reported.
Plain-English summary
ARTIS Icono biplane (model 11327600), ceiling (11328100) and floor (11327700) interventional fluoroscopic X-ray systems are being recalled. The quantity is not stated.
During patient examinations, the system may sporadically display a 0 X-ray dose administered to the patient. According to the manufacturer, this behaviour has only been observed during fluoroscopy and/or single-frame acquisitions, and despite the reported dose showing 0, an actual X-ray dose is applied to the patient. The FDA classified the action as Class II.
Distribution was in the United States and worldwide. The systems are installed in hospital interventional suites rather than sold to consumers.
Facilities should identify affected systems using the model numbers and UDI codes in the recall notice and follow the instructions issued by the manufacturer, including any guidance on reconstructing dose records.
The recalled product
- Product
- ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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