Z-0352-2009

OminDiagnost Eleva

Name: Z-0352-2009 OminDiagnost Eleva
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-12-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-12-10 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of OminDiagnost Eleva on 2008-12-10. The reason FDA records is "Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0352-2009
Status: Terminated
Initiated: 2008-12-10
Posted: 2009-09-24
Terminated: 2012-08-17
Recalling firm: Philips North America LLC
Product: OminDiagnost Eleva
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
FDA root cause: Radiation Control for Health and Safety Act
Action: An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C
Quantity in commerce: 69 units
Distribution: Worldwide Distribution
Product codes and lots: FCO 70800085 Equipment #'s 102666, 103056, 104083, 104136, 104530, 104838, 105194, 105394, 504340, 504341, 505039, 505345, 505346, 506236, 506247, 519141, 519142, 519574, 519952, 520020, 520046, 521113, 521977, 522220, 530589, 530777, 532087, 532140, 532151, 532213, 532703, 533112, 533314, 533471, 533473, 533559, 534247, 535257, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 539106, 539598, 539990, 540252, 541263, 541490, 543272, 544059, 545014, 545841, 546031, 547017, 547348, 549798, 553676, 558404, 42036161, 42383151, 43180366, 43180367, and 43680651,

Product code JAA

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)