Z-0874-03

OmniDiagnost System

Name: Z-0874-03 OmniDiagnost System
Creator: Philips Medical Systems Sales & Service Region No. America
Published: 2003-07-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2003-07-17 / Terminated / root cause: labeling and UDI

FDA source

Philips Medical Systems Sales & Service Region No. America began a recall of OmniDiagnost System on 2003-07-17. The reason FDA records is "Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0874-03
Status: Terminated
Initiated: 2003-07-17
Posted: 2004-07-20
Terminated: 2005-01-12
Recalling firm: Philips North America LLC
Product: OmniDiagnost System
Reason for recall: Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 7/17/03 the firm issued a letter dated June 12, 2003 to their customers advising that service personnel will visit the consignees and replace the buttons.
Quantity in commerce: 52
Distribution: The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
Product codes and lots: OmniDiagnost User Interface PN 9896 000 59561, 9896 000 12381, 9896 000 58161; The firm utilizes a ''site number'' specific to each unit: 101599, 103055, 103058, 100520, 100873, 101152, 101154, 101676, 101962, 102164, 102582, 102977, 103050, 103051, 103052, 103055, 103058, 103218, 103219, 104012, 104577, 104858, 104934, 105324, 105394, 13124, 38351, 50428, 76596, 76944, 76948, 82655, 83871, 83958, 84441, 84850, 85163, 85165, 86113, 86303, 86326, 86339, 86340, 86485, 86486, 86549, 86965, 86977, 87164, X1707, X1747, 104857

K982993Class IIPhilips OmnidiagnostPhilips Medical Systems, Inc. / cleared 1998-09-29

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)