Philips Recalls GEMINI TF Base CT/PET Systems Due to Software Defects
Philips is recalling two GEMINI TF Base CT/PET systems because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the source text explicitly states the defects may result in irradiation of healthy tissue or non-irradiation of diseased tissue, which constitutes a significant injury risk.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling two units of the GEMINI TF Base CT/PET System. The recall involves specific serial numbers 7111 and 7150, which were distributed worldwide, including in the United States, Australia, and various countries in Europe, Asia, and the Americas.
The recall is due to four identified software defects in the Tumor LOC software application. These defects may potentially result in the irradiation of healthy tissue or the non-irradiation of diseased tissue. The agency has classified this recall as Class II.
Healthcare facilities that have these specific units should contact Philips Medical Systems for further instructions on how to address the software defects.
The recalled product
- Product
- GEMINI TF Base 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.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — Imaging Systems
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model #882473 GEMINI TF Base (453567441711)
- Serial Number: 7111 & 7150.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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