—#116837

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution including USA (nationwide)

Timeline

Recall initiated: 2010-04-05
Posted by FDA: 2013-04-17
Terminated: 2021-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116837. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.