Philips Gemini LXL CT/PET Systems Recalled for Software Defects
Philips is recalling two Gemini LXL CT/PET systems due to software defects that may cause incorrect radiation delivery to patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with software defects that may result in the irradiation of healthy tissue or non-irradiation of diseased tissue, which constitutes a significant injury risk and fits the criteria for a Severe (Score 4) classification.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling two units of the GEMINI LXL CT/PET System. 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 systems are distributed worldwide, including in the United States, Australia, and various countries in Europe, Asia, and the Americas.
The specific units involved are Model #882412 GEMINI LXL with serial numbers 14702 and 14707. Healthcare facilities should contact Philips to address these software defects to ensure proper treatment delivery.
The recalled product
- 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 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 #882412 GEMINI LXL (459800018631)
- Serial Number: 14702 & 14707.
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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