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Recall Observatory FDA recall evidence

Device product

GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Z-2199-2015

July 01, 2015

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 71699
Status
Terminated
Classification
Class II
Quantity
44 Units
Official record key
device-enforcement:Z-2199-2015

Official wording

Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Code information: Model #882476 GEMINI TF Big Bore (453567473391); Serial Number: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9212, 9214, 9215, 9216, 9217, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226 & 9213.

Distribution pattern: Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software defects in the Tumor LOC software application that may potentially result in