Philips Medical Systems (Cleveland) Inc: TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on the GEMINI TF 16 and GEMINI TF 64 Slice PET/CT Systems, Catalog Numbers: 882470 - GEMINI TF 16 Slice; 882471 - GEMINI TF 64 Slice; and 882473 - GEMINI TF 16 Slice Base Configuration. Model Numbers: 4535 679 83931 - GEMINI TF 16 Slice; 4535 679 94741 - GEMINI TF-64 Slice and 4535 674 41711 - GEMINI TF 16 Slice Base Configuration. 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.

Recall number

Z-1578-2009

Recalling firm

Philips Medical Systems (Cleveland) Inc

Product

TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on the GEMINI TF 16 and GEMINI TF 64 Slice PET/CT Systems, Catalog Numbers: 882470 - GEMINI TF 16 Slice; 882471 - GEMINI TF 64 Slice; and 882473 - GEMINI TF 16 Slice Base Configuration. Model Numbers: 4535 679 83931 - GEMINI TF 16 Slice; 4535 679 94741 - GEMINI TF-64 Slice and 4535 674 41711 - GEMINI TF 16 Slice Base Configuration. 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.

Status

Terminated

Initiated

2009-02-19

Posted

2009-07-06

Terminated

2012-09-21

Reason

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

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

13 units

Distribution

Worldwide Distribution -- US, Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia.

Lot, serial or model codes

GEMINI TF 16 Slice, Serial Numbers: 7035, 7052, 7093, 7096, 7123, 7128, and 7133; GEMINI TF 16 Slice base configuration, Serial Number: 7150; and GEMINI TF 64 Slice, Serial Numbers: 7007, 7088, 7103, 7126, and 7132.

510(k) numbers

["K033326"]

PMA numbers

not on file

Product code

JAK

Firm FEI

1525965

Firm city

Cleveland

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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