—#95611

Product

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.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023441
Affected 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.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-03-06
Posted by FDA: 2011-01-18
Terminated: 2011-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95611. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.