Recall Z-0916-2011 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips EasyDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/universal system, general R/F, Fluoroscopy, Radiography, and Angiography can be performed along with pediatric examinations and some more specialized 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 | 39 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
| K031535 | PHILIPS EASYDIAGNOST ELEVA Philips Medical Systems North America Co., Jun 17, 2003 |