Brightview XCT, 3/8" 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 Recall Z-2155-2011 · Posted 2011-05-09
Advertisement
Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeKPS
Date Initiated2011-03-28
Date Terminated2011-06-22
Product Quantity49
Reason for Recall
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.
Firm Action
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.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement