Philips Ingenia MRI Systems Recalled for Table Movement Safety Issue
Philips is recalling Ingenia Elition S and X MRI systems because pressing the Stop Table button during automatic movement may cause the table to restart unexpectedly.
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 (MRI table movement) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.
Plain-English summary
Philips Medical Systems Nederlands is recalling 35 Ingenia Elition S and Ingenia Elition X MRI systems. The recall involves software version R5.5.0 and specific serial numbers listed in the agency record.
The recall is due to a safety issue where pressing and holding the 'Stop Table' button during automatic tabletop movement may lead to an unexpected restart of the table movement. This defect could pose a risk of injury to patients or operators.
The affected units were distributed in California, Minnesota, New Jersey, New York, Ohio, Tennessee, and Texas, as well as in Canada, Belgium, France, Germany, India, Japan, the Netherlands, South Africa, Sweden, Switzerland, and the UAE. Users should contact Philips Medical Systems for instructions on how to resolve the issue.
The recalled product
- Product
- Ingenia Elition S, Ingenia Elition X
- Manufacturer
- Philips Medical Systems Nederlands
- Category
- Medical Device — MRI Systems
- Hazard
- Affected units
- 35
Distribution
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