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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Computed Tomography XRay System

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 Class 2 Recall
Philips Healthcare Computed Tomography XRay System
see related information
Date Posted April 17, 2013
Recall Status1 Open
Recall Number Z-1003-2013
Recall Event ID 64708
Premarket Notification
510(K) Numbers
K012009  K013521  K032036  K033326  K033357  K041218 
K051170  K052640  K060937  K081135 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
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.
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
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer 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.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action Philips Healthcare proposed corrective action plan (CAP) is comprised of the following elements: * Updating procedures in manufacturing to verify, either through software calibration or through gage-pin measurement, that A-plane collimation is appropriate to the design specification. It is our understanding that these procedures have been implemented. * For refurbished PET/CT and SPECT/CT systems distributed by Philips, the manufacturing process now requires that CTDI testing be conducted in addition to air testing and that each system meet updated CTDI tolerance limits to be published in the product's instructions for use. * Reassessing and correcting the correlation between air dose and CTDI specifications for all CT systems or sub-systems, resulting in updates of the CTDI specifications (tolerances) to be published in the instructions for use. It is our understanding that this reassessment and correction have been implemented, that the updated CTDI specifications will be made available as new CTDI tolerance tables with the customer information letter to be distributed immediately, and that these updated CTDI specifications will also be distributed as an addendum to the instructions for use manuals to the installed base during the next 12 months. * For all Brilliance CT, Gemini PET/CT, and Precedence SPECT/CT systems, in the installed base as well as in forward production, instructions for field service will be updated to provide clear directions on how to verify that the A-plane collimator has been appropriately adjusted to ensure expected product performance after its replacement and/or the replacement of an x-ray tube. This plan appears to adequately address the problem, and it is hereby approved. For further questions please call (978) 687-1501.
Quantity in Commerce 2089 US 4036 ROW
Distribution Worldwide Distribution including USA (nationwide)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = ADAC LABORATORIES
510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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