Z-0366-2008

Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs...

Name: Z-0366-2008 Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2007-09-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-09-10 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. Philips Medical Systems... on 2007-09-10. The reason FDA records is "Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or...". 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-0366-2008
Status: Terminated
Initiated: 2007-09-10
Posted: 2007-12-29
Terminated: 2012-09-19
Recalling firm: Philips North America LLC
Product: Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. Philips Medical Systems, Cleveland, OH 44143. (The product is a software application that is installed in Philips Medical System CT scanners.)
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified of this recall by an Urgent Device Notification letter sent on 9/10/07. The letter instructed the users to not save any zoomed images to a batch file. Make all measurements of zoomed images in the CT viewer, which provides correct measurements. Do not perform measurements on any zoomed batched images that have been stored on a PACS System. Phillips in investigating the problem and will provide updates free of charge when completed.
Quantity in commerce: 2,544
Distribution: Worldwide Distribution - USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV, and WY, and country of Canada.
Product codes and lots: For 16 slice, 16 slice Big Bore, 40 slice, and 64 slice Brilliance CT scanners the affected software application versions are: 2.0, 2.0.2, 2.2, 2.2.1, 2.2.2, and 2.2.5. For Extended Brilliance Workspace the affected software application versions are: 2.0.0, 2.0.1, 2.0.50, 2.1.0, 3.0.0, 3.0.1, 3.0.2, 3.5, and 3.5.2.

Product code JAK

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)