Class 2 Device Recall Philips Healthcare Computed Tomography XRay System

• Date Initiated by Firm: April 05, 2010
• Date Posted: April 17, 2013
• Recall Status: Terminated on March 08, 2021
• Recall Number: Z-1003-2013
• Recall Event ID: 64708
• 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 MA 01810
• For Additional Information Contact: 978-687-1501
• 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.