Z-0911-2007

Philips Omni Diagnost Eleva

Name: Z-0911-2007 Philips Omni Diagnost Eleva
Creator: Philips Medical Systems North America Co. Phillips
Published: 2007-07-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-07-23 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips Omni Diagnost Eleva on 2007-07-23. The reason FDA records is "Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0911-2007
Status: Terminated
Initiated: 2007-07-23
Posted: 2007-09-25
Terminated: 2012-09-17
Recalling firm: Philips North America LLC
Product: Philips Omni Diagnost Eleva
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.
FDA root cause: Other
Action: On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.
Quantity in commerce: 14 units
Distribution: Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
Product codes and lots: Site numbers 500046, 520020, 521648, 522220, 533112, 533314, 533471, 533530, 535118, 535257, 535924, 539106, 540860, 541490

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)