Z-1580-2009

TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an...

Name: Z-1580-2009 TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2009-02-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-02-19 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an accessory for the GEMINI PET/CT Systems running CT... on 2009-02-19. The reason FDA records is "A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units. The software...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1580-2009
Status: Terminated
Initiated: 2009-02-19
Posted: 2009-07-06
Terminated: 2012-09-21
Recalling firm: Philips North America LLC
Product: TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an accessory for the GEMINI PET/CT Systems running CT software versions 3.5.x. , CT host 2.2. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units. The software defect results in a the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
Root cause tag: software
FDA root cause: Software design
Action: An "URGENT - Field Safety Notice" dated February 12, 2009 was sent via FedEx to domestic customers. The notice described the affected products, issue, involved hazard should problem occur and corrective actions for the customer/user. The letter also notified users/customers that a Philips Healthcare Field Service Engineer will contact and visit their site within 6 months to install a TumorLoc upgrade. Notification will also be sent to the international consignees by Philips personnel. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.
Quantity in commerce: 11 units
Distribution: Worldwide Distribution -- US, Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia.
Product codes and lots: Serial Numbers: 7909, 8940, 8804, 9019, 10331, 10348, 10701, 11555, 55110, 55172 and 55180.

Product code KPS

K052640Class IIGemini RaptorPhilips Medical Systems (Cleveland), Inc. / cleared 2005-10-07

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)