Philips Gemini GXL 16 Slice CT Systems Recalled for UPS Battery Hazards
Philips is recalling 15 Gemini GXL 16 Slice CT systems worldwide because their UPS accessory devices 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 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 is classified as FDA Class II and involves significant injury risks, including battery acid leakage, overheating, and fume emission, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 15 units of the Gemini GXL 16 Slice Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall involves specific Uninterruptible Power Supply (UPS) accessory devices used with these systems. The affected units are identified by Model # 882410 and specific serial numbers listed in the recall notice.
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 rather than the primary imaging functions of the CT systems.
The affected units were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations. Healthcare facilities and users of these specific serial numbers should contact Philips Medical Systems for instructions on how to address the defect.
The recalled product
- Product
- Gemini GXL 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
- 15
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 (15)
- Model #: 882410
- Serial #s: 3025
- 4003
- 4026
- 4067
- 4076
- 4087
- 4097
- 4102
- 4123
- 4134
- 4201
- 4202
- 4205
- 4206 & 4042003.
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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