Date Initiated by Firm |
September 28, 2007 |
Date Posted |
February 08, 2008 |
Recall Status1 |
Terminated 3 on February 04, 2009 |
Recall Number |
Z-0676-2008 |
Recall Event ID |
45329 |
510(K)Number |
K041218
|
Product Classification |
Pulse Doppler Ultrasonic Imaging System - 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 CA 95035-7443
|
For Additional Information Contact |
408-321-9100
|
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 |
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
|
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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.
|
510(K) Database |
510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES
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