FDAClass IIJuly 29, 2015

GEMINI TF Ready CT/PET System. The Philips GEMINI recall: Software Issue

GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and…

Why was GEMINI TF Ready CT/PET System. The Philips GEMINI recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model #882473 GEMINI TF Ready (453567441711); Serial Number: 7237.

Product
GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
1 unit
Distribution
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.
Recall date
July 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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