Z-1374-2008

Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic...

Name: Z-1374-2008 Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-03-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-03-22 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications on 2008-03-22. The reason FDA records is "Unexpected movement of the X-ray table may occur. These movements may lead to patient injury, e.g., an uncontrolled tilt may cause the patient to slip off". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1374-2008
Status: Terminated
Initiated: 2008-03-22
Posted: 2008-09-16
Terminated: 2010-09-17
Recalling firm: Philips North America LLC
Product: Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Unexpected movement of the X-ray table may occur. These movements may lead to patient injury, e.g., an uncontrolled tilt may cause the patient to slip off.
Root cause tag: software
FDA root cause: Software design
Action: On 3/22/08, the firm mailed letters to their customers via certified mail. The letter informed the customers of the recall, advising the customers to, "Use the emergency stop button or release the initiated movement command to halt undesired table movement. If you perform digital and conventional acquisition, you can avoid the problem by closing the single examinations daily or by clearing the patient database regularly." The letter further informed the customers that a Philips representative will be installing updated software at a future date. Contact Sarah Baxter at 425-487-7665 or Philips Call Center at 800-722-9377, #5, #2 if you have questions.
Quantity in commerce: 22 units
Distribution: Nationwide Distribution -- including states of CA, CO, KY, TN, LA, MI, FL, MS, TX, VA, WI, MO, AZ, and NY.
Product codes and lots: Product number 9896 002 04432. SN number: 43, 49, 52, 107, 123, 131, 152, 157, 171, 179, 185, 202, 266, 333, 337, 389, 408, 446, 485, 491, 514, 515; Site ID #: 506241, 500046, 521648, 522220, 520020, 533112, 533314, 533471, 533530, 535257, 535118, 535924, 540860, 541490, 539106, 547017, 547142, 549798, 547348, 550258, 553676, 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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)