Philips Ingenia 3.0T CX MRI Machine Carrier Assembly Screws May Loosen
Philips Ingenia 3.0T CX MRI machines may have loose screws in the RF carrier assembly that could protrude and interfere with the tabletop mechanism, potentially delaying patient scans.
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 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 Class II recall involves a mechanical defect with no reported incidents or injuries. The primary risk is operational disruption and potential diagnostic delays, with secondary concerns about patient anxiety. The precautionary nature and lack of reported harm place this at the moderate severity level.
Plain-English summary
Philips North America LLC is recalling Ingenia 3.0T CX magnetic resonance imaging (MRI) machines distributed worldwide, including throughout the United States and to over 50 countries. A total of 8 units are affected.
The screws in the Integrated Radio Frequency (IRF) Carrier assembly may become loose and protrude beyond the device surface. These loose screws could interfere with moving parts of the device, potentially blocking the horizontal tabletop and disrupting normal operation.
If the tabletop becomes blocked, it could delay patient scans and cause patients to remain inside the MRI bore longer than anticipated, leading to patient anxiety. The FDA classified this as a Class II recall. No injuries or illnesses have been reported to date. Affected healthcare facilities should contact Philips for guidance on identifying and addressing affected units.
The recalled product
- Product
- Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782105
- Manufacturer
- Philips North America Llc
- Affected units
- 8
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Philips North America Llc 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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