Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tom...
FDA Recall #Z-1003-2013 — Class II — April 5, 2010
Product Description
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.
Reason for Recall
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.
Recalling Firm
Philips Healthcare Inc. — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2089 US 4036 ROW
Distribution
Worldwide Distribution including USA (nationwide)
Code Information
Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10,16, 16P, 40, 64, and Big Bore), Brilliance iCT, Brilliance iCT SP
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated