Z-0905-2011

BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography

Name: Z-0905-2011 BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography
Creator: Philips Healthcare Inc.
Published: 2011-01-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-01-17 / Terminated

FDA source

Philips Healthcare Inc. began a recall of BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography on 2011-01-17. The reason FDA records is "Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0905-2011
Status: Terminated
Initiated: 2011-01-17
Posted: 2011-03-04
Terminated: 2020-08-11
Recalling firm: Philips North America LLC
Product: BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.
Product code: IZO Generator, High-Voltage, X-Ray, Diagnostic
Reason for recall: Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously.
FDA root cause: Radiation Control for Health and Safety Act
Action: A Customer Information BuckyDiagnost Diagnostic X-Ray System letter, dated January 6, 2011, was sent to customers. The letter identifies the affected product, the reason for the recall, actions that are to be taken by customers, and actions that are planned by the firm. Customers are advised to make sure that the desired exposure values are displayed and that they have released the technique button BEFORE they start the exposure by pressing the exposure switch whenever manually changing the exposure parameters and in order to avoid the problem. Philips will issue a Field Change Order (FCO) to resolve the issue by updating the system software free of charge. Philips will contact customers to implement the FCO. Further information or support concerning this issue can be obtained by contacting your local Philips representative. The Field Service Engineers began software implementation the week of March 21, 2011.
Quantity in commerce: 1810 units in the US
Distribution: Worldwide Distribution
Product codes and lots: 704031 / 70408

Product code IZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)