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U.S. Department of Health and Human Services

Class 2 Device Recall Precedence SPECT/CT System

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 Class 2 Recall
Precedence SPECT/CT System
see related information
Date Posted February 08, 2008
Recall Status1 Terminated on February 04, 2009
Recall Number Z-0676-2008
Recall Event ID 45329
Premarket Notification
510(K) Number
K041218 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips Nuclear Medicine, Milpitas, CA 95035
Code Information Model Numbers: 2169-3000A/453560250851; 2169-3001A/453560250861; 2169-3002A/453560253551; and 2169-3003A/453560253561
Recalling Firm/
Manufacturer
Phillips Nuclear Medicine
540 Alder Dr Bldg 4
Milpitas, California 95035-7443
Manufacturer Reason
for Recall
Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software application options used in the Precedence CT Sub-System. The defect causes incorrect measurements in derived images which are zoomed and saved in a batch file.
FDA Determined
Cause 2
DESIGN: Software Design
Action A Customer Advisory Notification was mailed to affected consignees on September 28, 2007. The firm informed consignees that incorrect measurement can occur when the Cardiac Viewer or Pulmonary Viewer is used to zoom and save derived images in batch files. The firm provided instructions for operators to prevent incorrect measurements. Phillips is currently investigating methods to correct this issue and will provide updates, free of charge, when they become available. If you have questions concerning this recall, please contact Phillips Medical at 1-800-722-9377, (option5: Diagnostic Imaging, option 5:NM).
Quantity in Commerce 19
Distribution Worldwide Distribution --- USA including states of FL, NY, VT, MD, TX, and MO and country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES
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