Z-0918-2011

Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips OmniDiagnost Eleva is a...

Name: Z-0918-2011 Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips OmniDiagnost Eleva is a...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2009-03-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-03-06 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic... on 2009-03-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0918-2011
Status: Terminated
Initiated: 2009-03-06
Posted: 2011-01-18
Terminated: 2011-06-16
Recalling firm: Philips North America LLC
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.
Product code: IZI System, X-Ray, Angiographic
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.
FDA 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 in commerce: 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.
Product codes and lots: Site Numbers: 533530, 535118, 535257, 535924, 539106, 540860, 541490, 547017, 547142, 547348, 549798, 550258, and 553235.

Product code IZI

K032046Class IIPhillips Omnidiagnost ElevaPhilips Medical Systems, Inc. / cleared 2003-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)