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Artis pheno system
Official notice
28 Sept 2022
Last checked
28 Sept 2022
An official Health Canada notice concerns Artis pheno system. The Artis Pheno System is provided with a dedicated error management mechanism. In rare cases of specific X-ray tube failures, the system is intended to automatically switch over to "bypass fluoroscopy" mode. However, in case such a failure occurs while the "block radiation" functionality is active, the "block radiation" functionality cannot be unlocked, and the system will not switch over to "bypass fluoroscopy" mode. In "bypass fluoroscopy" mode a limited imaging functionality (nonsubtracted, Continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available. Recall start date: September 23, 2022 Published 2022-09-28.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64587
Official notice
2022-09-28
The hazard
The hazard
The Artis Pheno System is provided with a dedicated error management mechanism. In rare cases of specific X-ray tube failures, the system is intended to automatically switch over to "bypass fluoroscopy" mode. However, in case such a failure occurs while the "block radiation" functionality is active, the "block radiation" functionality cannot be unlocked, and the system will not switch over to "bypass fluoroscopy" mode. In "bypass fluoroscopy" mode a limited imaging functionality (nonsubtracted, Continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available. Recall start date: September 23, 2022
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Siemens, Artis Pheno System.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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