Philips Recalls GEMINI TF Big Bore CT/PET Systems Due to Software Defects
Philips is recalling 44 GEMINI TF Big Bore CT/PET systems worldwide because four software defects in the Tumor LOC application 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 (medical device) where injury has not yet been reported, fitting the High severity criteria for potential harm without confirmed adverse events.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 44 units of the GEMINI TF Big Bore CT/PET System. These integrated diagnostic imaging systems are 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 affected units are identified by Model #882476 and specific serial numbers listed in the agency record.
Healthcare facilities and consumers should contact Philips Medical Systems (Cleveland) Inc for further instructions regarding the recall and necessary corrective actions.
The recalled product
- Product
- GEMINI TF Big Bore 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 System
- Affected units
- 44
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 (20)
- Model #882476 GEMINI TF Big Bore (453567473391)
- Serial Number: 9004
- 9005
- 9006
- 9008
- 9009
- 9010
- 9011
- 9012
- 9013
- 9014
- 9015
- 9016
- 9017
- 9018
- 9019
- 9020
- 9021
- 9022
- 9023
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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