Philips MultiDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips MultiDiagnost Eleva is intended use as a multi-functional universal system, general RF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications.
This recall has been terminated (originally issued January 18, 2011).
- Recall Initiated
- March 6, 2009
- Posted
- January 18, 2011
- Terminated
- June 16, 2011
- Recall Number
- Z-0917-2011
- Quantity
- 43 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Site Numbers: 105193, 505346, 506247, 520046, 532151, 532213, 534247, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 539457, 539598, 539990, 540252, 541263, 541474, 543272, 544059, 545014, 545156, 545198, 545841, 546031, 546578, 549417, 551519, 553138, 553139, 553140, 553287, 554015, 554687, 554689, 554730, 556197, and 42381879.
Root Cause
Other
Action Taken
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 their units. The consignees can contact Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference "FCO 70800070" with any questions about this recall.