Z-0676-2008

Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with...

Name: Z-0676-2008 Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with...
Creator: Phillips Nuclear Medicine
Published: 2007-09-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-09-28 / Terminated / root cause: software

FDA source

Phillips Nuclear Medicine began a recall of Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW... on 2007-09-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0676-2008
Status: Terminated
Initiated: 2007-09-28
Posted: 2008-02-08
Terminated: 2009-02-04
Recalling firm: Philips North America LLC
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
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: software
FDA 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, 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.
Product codes and lots: Model Numbers: 2169-3000A/453560250851; 2169-3001A/453560250861; 2169-3002A/453560253551; and 2169-3003A/453560253561

Product code KPS

K041218Class IIGriffin Spect/ct Imaging SystemAdac Laboratories / cleared 2004-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)