The Recall Desk
HighFDA (Devices)·Z-0694-2019·Announced 2019-01-16

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.

What this means for you

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
Affected units
35

Distribution

Distributed in 7 states:

Same manufacturer · Philips Medical Systems Nederlands

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