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U.S. Department of Health and Human Services

Class 2 Device Recall Brightview XCT, 3/4"

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  Class 2 Device Recall Brightview XCT, 3/4" see related information
Date Initiated by Firm March 28, 2011
Date Posted May 09, 2011
Recall Status1 Terminated 3 on June 22, 2011
Recall Number Z-2156-2011
Recall Event ID 58323
510(K)Number K080927  
Product Classification System, tomography, computed, emission - Product Code KPS
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.
Code Information Model number: 4535-604-62131: catalog number 882350; Serial number: 6340008. 
Recalling Firm/
Manufacturer		 Philips Medical Systems
3860 N 1st St
San Jose CA 95134-1702
For Additional Information Contact Elizabeth McLain
408-468-3000
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 1
Distribution 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.
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.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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