Recall Z-0367-2008 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
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.)
| Date | Dec 29, 2007 (initiated Sep 10, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.