Devices

Device Recall "PHILIPS PLUS" COMPUTED TOMOGRAPHY SYSTEM

Model / Serial
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.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US, Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia.
Product Description
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.
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
- Recall of Device Recall "PHILIPS PLUS" COMPUTED TOMOGRAPHY SYSTEM

Manufacturer

Philips Medical Systems (Cleveland) Inc

Manufacturer Address
Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
Source
USFDA

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