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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
Site Numbers: 6931, 6934, 25834, 25901, 26140, 38086, 38195, 38196, 38279, 38500, 38539, 41111, 44282, 44656, 44657, 45070, 50230, 64158, 73286, 80306, 82503, 82630, 82646, 84939, 86395, 100727, 101142, 101555, 102034, 102169, 102590, 102591, 103421, 104104, 104810, 520185, 557985, 558101, and 558174.
Products Sold
Site Numbers: 6931, 6934, 25834, 25901, 26140, 38086, 38195, 38196, 38279, 38500, 38539, 41111, 44282, 44656, 44657, 45070, 50230, 64158, 73286, 80306, 82503, 82630, 82646, 84939, 86395, 100727, 101142, 101555, 102034, 102169, 102590, 102591, 103421, 104104, 104810, 520185, 557985, 558101, and 558174.
Philips Medical Systems North America Co. Phillips is recalling Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips EasyDiagnost Eleva int due to 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 po. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026