Recall Z-0676-2008 ยท KPS System, Tomography, Computed, Emission
Phillips Nuclear Medicine
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
| Date | Feb 8, 2008 (initiated Sep 28, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 19 |
| Distribution | Worldwide Distribution --- USA including states of FL, NY, VT, MD, TX, and MO and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041218 | GRIFFIN SPECT/CT IMAGING SYSTEM Adac Laboratories, May 24, 2004 |