Recall Z-0918-2011 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
| Date | Jan 18, 2011 (initiated Mar 6, 2009) |
| Status | Terminated |
| Reason | Images from two different patients may be combined in one patient folder in the Digital Image (DI) or may be combined as one (printed) image. It is possible that an image of a previous patient registered in the DI will be overwritten with an image of a later patient. |
| Root cause | Other |
| Action | On March 6, 2009, Philips sent an "URGENT-Device Correction Easy Diagnost Eleva, MultiDiagnost Eleva, and OmniDiagnost Eleva with DI Rel. 2 systems notification" to their consignees/customers. The consignees/customers are advised that before diagnosing images, always check the stored (Digital Image, Viewform or PACS) or printed images to ensure that these represent the data and images captured from the examination of the respective patient. Do not use images if they do not represent the patient that was examined. Consignees will be contacted by Philips to schedule a software upgrade of thei |
| Quantity | 13 units |
| Distribution | Nationwide distribution: USA including states of: AZ, CA, CO, CT, DE, FL, GA, HI, ID, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032046 | PHILLIPS OMNIDIAGNOST ELEVA Philips Medical Systems, Inc., Jul 17, 2003 |