Philips Gemini GXL CT/PET System Software Recall for Tumor LOC Defects
Philips is recalling two Gemini GXL 16 Slice CT/PET systems due to software defects in the Tumor LOC application that may cause incorrect tissue irradiation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, specifically the potential for incorrect irradiation of tissue, which aligns with the High severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling two units of the GEMINI GXL 16 Slice CT/PET System. The affected devices are identified by Model #882410 and Serial Numbers 4170 and 4147A. These systems were distributed worldwide, including in the United States, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela, and Vietnam.
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 source text does not report any specific injuries or illnesses associated with these defects.
Healthcare facilities and users of these specific serial numbers should contact Philips Medical Systems for further instructions regarding the software defects and necessary corrective actions.
The recalled product
- Product
- GEMINI GXL 16 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.
- 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 #882410 GEMINI GXL 16 Slice (453567971891)
- Serial Number: 4170 & 4147A.
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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