Health Products

ARTIS Pheno

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: ARTIS Pheno
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
ARTIS Pheno16412310849000
ARTIS Pheno16410110849000

Issue

Initiating a shutdown of the system can sporadically lead to a state in which the robotic C-arm stand cannot be moved after the next system startup. Other movements (e.g. table movements) are still available with reduced speed. The system may show the following generic messages "reduced stand/table speed" and "limited stand movement, wait". In case the error occurs the C-arm stand will not move anymore. Therefore, the C-arm cannot be moved into the required position. This may result in a situation where it is necessary to cancel the clinical procedure or to begin or continue the procedure on an alternative system. Recall start date: August 13, 2025

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