ARTIS pheno systems may display zero dose while dose is applied
ARTIS pheno 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
The ARTIS pheno interventional fluoroscopic X-ray system, model 10849000, UDI 4056869046877, is 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 number and UDI above and follow the instructions issued by the manufacturer, including any guidance on reconstructing dose records.
The recalled product
- Product
- ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
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 (1)
- UDI: 4056869046877
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.
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