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Recall Observatory FDA recall evidence

Device product

GEMINI TF 64 Slice 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-2196-2015

July 01, 2015

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 71699
Status
Terminated
Classification
Class II
Quantity
22 Units
Official record key
device-enforcement:Z-2196-2015

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 #882471 GEMINI TF 64 Slice (453567994741); Serial Number: 7007, 7012, 7042, 7055, 7083, 7103, 7116, 7126, 7132, 7158, 7160, 7164, 7169, 7175, 7179, 7218, 7221, 7229, 7245, 7255, 7256 & 7552.

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