—#98993

Product

Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat panel x-ray imaging components. Brightview ECT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K080927
Affected lot / code info: Model number: 4535-604-62131: catalog number 882350; Serial number: 6340008.

Why it was recalled

The current Headholder to support Bright View XCT brain imaging allowed for imaging the brain but doe allow for imaging of the associated shoulder/neck area of the body.

Root cause (FDA determination)

Device Design

Action the firm took

Customer information sheets will be provided to all customers when the field change order commences in April 2011. Philips will implement a full change order for the installation of the new headholder to replace the old headholder, free of charge, to all affected Philips BrightView XCT SPECT/CT units. For questions regarding this recall call 408-463-3000.

Recalling firm

Firm: Philips Medical Systems
Address: 3860 N 1st St, San Jose, California 95134-1702

Distribution

Distribution pattern: Worldwide Distribution - USA including US distribution to OH, MA, FL, VT and KY and the countries of Norway, Saudi Arabia, Belgium, Brazil, Japan, China, Poland, Austria, United Kingdom, Spain, Indonesia, Malaysia, Taiwan, Germany, United Arab Emirates, Netherland, Switzerland, Ireland, Czech Republic and Canada.

Timeline

Recall initiated: 2011-03-28
Posted by FDA: 2011-05-09
Terminated: 2011-06-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.