Z-0563-03

Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335

Name: Z-0563-03 Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335
Creator: Philips Medical Systems Inc
Published: 2003-01-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2003-01-23 / Terminated

FDA source

Philips Medical Systems Inc began a recall of Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335 on 2003-01-23. The reason FDA records is "The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0563-03
Status: Terminated
Initiated: 2003-01-23
Posted: 2003-02-21
Terminated: 2008-10-29
Recalling firm: Philips North America LLC
Product: Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.
FDA root cause: Other
Action: The firm mailed a ''Customer Advisory Notice'' to all affected customers on 1/23/2003.
Quantity in commerce: 311 units
Distribution: The sytems were shipped to end-users located nationwide and worldwide.
Product codes and lots: All serial numbers of Models N210060 and N210335.

Product code KPS

K882312Class IModel 3000 Nuclear CameraOhio Imaging, Inc. / cleared 1988-07-14

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)