Philips Recalls GEMINI TF PET/CT 16 Slice UPS Accessory Devices
Philips is recalling 69 GEMINI TF PET/CT 16 Slice systems due to UPS accessory devices that may leak battery acid, overheat, or emit fumes.
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 (battery acid leakage, overheating, fumes) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 69 units of the GEMINI TF PET/CT 16 Slice Computed Tomography X-ray and Diagnostic Imaging systems. The recall involves Uninterruptible Power Supply (UPS) accessory devices used in conjunction with these systems.
The firm was notified that the failure of these UPS accessory devices may result in battery acid leakage, overheating, and/or emission of fumes. The affected units are distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations.
The source text does not specify specific actions for consumers or healthcare providers, such as stopping use or contacting a representative. Affected units are identified by Model 882456 and specific serial numbers listed in the recall documentation.
The recalled product
- Product
- GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 69
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: 882456
- Serial #s: 2019
- 2021
- 2022
- 2023
- 2024
- 2025
- 2026
- 2027
- 7018
- 7038
- 7208
- 7210
- 7211
- 7215
- 7216
- 7223
- 7224
- 7226
- 7228
Distribution
Part of a larger recall action
This product is one of 35 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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