GEMINI LXL CT/PET System. The Philips GEMINI PET/CT recall: Software Issue
GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron…
Why was GEMINI LXL CT/PET System. The Philips GEMINI PET/CT 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 #882412 GEMINI LXL (459800018631); Serial Number: 14702 & 14707.
- Product
- GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 2 units
- 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)