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Class 2 Device Recall Brightview XCT, 3/4" |
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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
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Product Classification |
System, tomography, computed, emission - Product Code KPS
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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
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For Additional Information Contact |
Elizabeth McLain 408-468-3000
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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