Devices

Device Recall GEMINI RAPTOR

Model / Serial
Serial Numbers: 7909, 8940, 8804, 9019, 10331, 10348, 10701, 11555, 55110, 55172 and 55180.
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 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.
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
- Recall of Device Recall GEMINI RAPTOR

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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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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