—#64364

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.)

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009, K033326, K033357
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-09-10
Posted by FDA: 2007-12-29
Terminated: 2012-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64364. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.