FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0918-2011
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-03-06
- Posted
- 2011-01-18
- Terminated
- 2011-06-16
- 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 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.
- 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.
- Lot, serial or model codes
- Site Numbers: 533530, 535118, 535257, 535924, 539106, 540860, 541490, 547017, 547142, 547348, 549798, 550258, and 553235.
- 510(k) numbers
- ["K032046"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28