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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64708
Product Type Devices
Status Ongoing
Recalling Firm Philips Healthcare Inc.
City Andover
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-04-05
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution including USA (nationwide)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II 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. 2089 US 4036 ROW Z-1003-2013
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