Philips Recalls Gemini 16 PET/CT Uninterruptible Power Supply Accessories
Philips is recalling 7 Gemini 16 PET/CT Uninterruptible Power Supply units worldwide due to risks of battery acid leakage, overheating, and 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, which aligns with the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 7 Uninterruptible Power Supply (UPS) accessory devices used with the Gemini 16 PET/CT System. The recall covers units distributed in the United States and numerous countries worldwide.
The recall was initiated because the UPS accessory devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. The affected units are identified by Model # 882300 and specific serial numbers: 1041, 1045, 5001, 1072R, 1075R, 1076R, and G074.
The source text does not specify the corrective action or instructions for affected users. No illnesses or injuries are reported in the provided text.
The recalled product
- Product
- Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 7
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 (7)
- Model #: 882300
- Serial #s: 1041
- 1045
- 5001
- 1072R
- 1075R
- 1076R & G074.
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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