Philips Gemini LXL 16 Slice CT Systems Recalled for UPS Defects
Philips is recalling 10 Gemini LXL 16 Slice CT systems worldwide due to UPS accessory defects that may cause battery acid leakage, overheating, or 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 for theoretical hazards without confirmed harm.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 10 units of the Gemini LXL 16 Slice Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall involves Uninterruptible Power Supply (UPS) accessory devices associated with these systems. The affected units are identified by Model # 882412 and specific serial numbers ranging from 14701 to 14711.
The recall was initiated because the UPS accessory devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. These hazards are associated with the power supply components used in conjunction with the imaging systems.
The affected products were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations. The source text does not specify instructions for consumers or healthcare facilities regarding the immediate handling of these devices, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- Product
- Gemini LXL 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
- 10
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 (10)
- Model #: 882412
- Serial #s: 14701
- 14702
- 14704
- 14705
- 14706
- 14707
- 14708
- 14709
- 14710 & 14711.
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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