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U.S. Department of Health and Human Services

Class 2 Device Recall Brightview XCT, 3/8"

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 Class 2 Device Recall Brightview XCT, 3/8"see related information
Date Initiated by FirmMarch 28, 2011
Date PostedMay 09, 2011
Recall Status1 Terminated 3 on June 22, 2011
Recall NumberZ-2155-2011
Recall Event ID 58323
510(K)NumberK080927 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductBrightview 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.
Code Information Model number: 4535-607-49161, catalog number 882482; Serial numbers: 6000150 6000114 6000106 6000071 6000107 6000139 6000138 6000131 6000130 6000128 6000126 6000125 6000123 6000121 6000163 6000156 6000151 6000147 6000145 6000144 6000141 6000120 6000119 6000118 6000109 6000105 6000104 6000103 6000102 6000099 6000098 6000097 6000096 6000088 6000085 6000080 6000077 6000067 6000066 6000041 6000015 6000012 6000010 6000005 6000084 6000074 6000072 6000070 6000065.  
FEI Number 1525965
Recalling Firm/
Manufacturer		 Philips Medical Systems
3860 N 1st St
San Jose CA 95134-1702
For Additional Information ContactElizabeth 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
ActionCustomer 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 Commerce49
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = KPS
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