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New Search Back To Search Results   Medical Device Recalls Class 2 Recall Pulmonary Viewer Date Recall Initiated September 10, 2007 Date Posted December 29, 2007 Recall Number Z-0367-2008 Product Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Brilliance CT scanners using software versions 2.0 through V 2.2.5 and all EBW workstations using software versions 2.0 through V3.5.2. Philips Medical Systems, Cleveland, OH 44143. (The product is a software application that is installed in Philips Medical System CT scanners.) Code Information 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. Recalling Firm/ Manufacturer Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland , Ohio 44143-2131 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. 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.

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