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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 Firm June 15, 2011
Date Posted August 04, 2011
Recall Status1 Terminated 3 on February 15, 2013
Recall Number Z-2948-2011
Recall Event ID 59252
510(K)Number K080927  
Product Classification Single Phonton Emission Tomography (SPECT) System - Product Code KPS
Product BrightView 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 Contact Elizabeth 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
Action Philips 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 Commerce 213 units, all systems
Distribution Worldwide 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 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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