Medical Device MRI Cooling Cabinet Warning Label Missing High-Voltage Symbol
Philips Ingenia Ambition X MRI systems contain an incorrect warning label on the cooling cabinet. The label is missing high-voltage warning symbols, creating a potential electrical shock risk for service personnel.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a labeling defect with no reported injuries. The hazard is theoretical (potential electrical shock to service personnel), and Class III recalls are typically assigned scores of 1–2.
Plain-English summary
Philips North America is recalling the Ingenia Ambition X, Model No. 782109 MRI systems due to an incorrect warning label on the Liquid Cooling Cabinet (LCC). The caution symbol on the label has a white background instead of the required yellow background, and the label is missing the high voltage warning symbol.
The incorrect labeling presents a potential risk of electrical shock to service personnel who work on the MRI system. Without proper warning symbols, technicians may not recognize the electrical hazard present in the cooling cabinet.
The recall affects 7 units distributed in the United States (Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska, and Texas) and 16 units distributed worldwide in Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
Service personnel should contact Philips North America or refer to the full FDA notice for instructions on obtaining the corrected warning labels.
The recalled product
- Product
- Ingenia Ambition X, Model No. 782109
- Manufacturer
- Philips North America
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 (1)
- Model No. 782109 UDI-DI 00884838098350 Serial Number 47785
Distribution
Part of a larger recall action
This product is one of 6 recalled by Philips North America 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.
See all 6 products in this recall →Related recalls
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