Z-1665-2009

OmniDiagnost

Name: Z-1665-2009 OmniDiagnost
Creator: Philips Medical Systems North America Co. Phillips
Published: 2009-07-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-07-06 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of OmniDiagnost on 2009-07-06. The reason FDA records is "The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific 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-1665-2009
Status: Terminated
Initiated: 2009-07-06
Posted: 2009-09-24
Terminated: 2011-12-16
Recalling firm: Philips North America LLC
Product: OmniDiagnost
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific 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: A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009.
Quantity in commerce: 28 units
Distribution: Worldwide Distribution
Product codes and lots: N/A

Product code JAA

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