Siemens Medical Solutions USA recalled 758 units in the U.S. and 2,077 outside the U.S. of ARTIS pheno and ARTIS Icono imaging systems after a dose-display anomaly could misrepresent high X-ray doses. The devices may still be within regulatory dose limits, but the displayed dose may appear significantly higher. Clinicians should stop using the devices and await manufacturer guidance.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions
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ARTIS pheno and ARTIS Icono are advanced imaging systems used in interventional radiology and diagnostic imaging to visualize internal anatomy with X-ray based guidance.
The display may erroneously indicate a high X-ray dose to the patient. The actual dose remains within regulatory limits, but the misrepresentation can affect clinical decisions.
This recall is not part of a broader industry pattern currently disclosed.
Facilities may experience workflow disruption and potential need for temporary alternatives while awaiting remediation.
Device UID stickers and the manufacturer’s recall communications contain the identifying codes.
Remedy procedures will be provided by Siemens after the recall is acknowledged by facilities. Expect weeks to months for replacement or repair.
Record device identifiers, recall numbers, and all communications with vendor and risk management.
Brand: Siemens Medical Solutions USA. Product: ARTIS pheno and ARTIS Icono biplane, floor and ceiling imaging systems. Models/UDI: ARTIS pheno UDI 4056869046877; ARTIS Icono biplane UDI 4056869063317; ARTIS Icono ceiling UDI 4056869295923; ARTIS Icono floor UDI 4056869149325. Quantity: U.S. 758; OUS 2077. Distribution: Worldwide including the United States.
No specific injuries or incidents are provided in the recall notice. The hazard is a display anomaly related to dose indication.
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