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Philips Healthcare Inc. recalls Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray sys
Recalled April 24, 2013 · FDA recall Z-1003-2013 · Philips Healthcare
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. · FDA Class II
Units
2089 US 4036 ROW
Sold at
Worldwide Distribution including USA (nationwide)
Description
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.
Product
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.
Manufacturer(s)
Philips Healthcare Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →