FDA-Device2013-04-24Class II
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
Philips Healthcare Inc.
Hazard
Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.
Sold states
Worldwide Distribution including USA (nationwide)
Affected count
2089 US 4036 ROW
Manufactured in
3000 Minuteman Road, N/A, Andover, MA, United States
Products
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1003-2013Don't want to check this manually?
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