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U.S. Department of Health and Human Services

Class 2 Device Recall BrightView XCT Gamma Camera, 3/8".

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 Class 2 Device Recall BrightView XCT Gamma Camera, 3/8".see related information
Date Initiated by FirmJune 15, 2011
Date PostedAugust 04, 2011
Recall Status1 Terminated 3 on February 15, 2013
Recall NumberZ-2948-2011
Recall Event ID 59252
510(K)NumberK080927 
Product Classification Single Phonton Emission Tomography (SPECT) System - Product Code KPS
ProductBrightView XCT Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
Code Information Model Number: 4535-604-262131. Catalog # 882482. Running system 2.0.1.
Recalling Firm/
Manufacturer		 Philips Medical Systems
3860 N 1st St
San Jose CA 95134-1702
For Additional Information ContactElizabeth McLain
608-288-6948
Manufacturer Reason
for Recall		Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.
FDA Determined
Cause 2		Software design
ActionPhilips Medical Systems, Inc. set a "Customer Information" letter dated July 8, 2011 to all affected customers. The letter informed them of an upcoming software updated (version 2.5). For questions please contact 800-722-9377 (option 5).
Quantity in Commerce213 units, all systems
DistributionWorldwide Distribution: (USA) Nationwide distribution and the countries of Greece, Australia, Belgium, China, Czech Republic, France, Germany, Indonesia, Israel, Japan, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan U.A.E., and the UK.
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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