Devices

Device Recall The Brilliance 64 and Ingenuity CT Computed Tomography Scanners

Model / Serial
System Code # 728231, Serial #s: 91003, 95157, 9654, 95130, and 95504 System Code # 728326, Serial #s: 300010, 300030, and 300018
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including IN and OH, also, the countries of Australia, Belgium, China, Israel, and Sweden
Product Description
The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
- Recall of Device Recall The Brilliance 64 and Ingenuity CT Computed Tomography Scanners

Manufacturer

Philips Medical Systems (Cleveland) Inc

Manufacturer Address
Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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