Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SP
FDA device recall Z-0676-2008 · posted 2008-02-08 · Terminated
Recall details
- Recalling firm
- Phillips Nuclear Medicine
- 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.
- Action taken
- 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).
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 19
- Distribution
- Worldwide Distribution --- USA including states of FL, NY, VT, MD, TX, and MO and country of Canada.
- Date initiated
- 2007-09-28
- Date posted
- 2008-02-08
- Date terminated
- 2009-02-04
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRIFFIN SPECT/CT IMAGING SYSTEM (K041218) | Adac Laboratories | 2004-05-24 |