Medical device recalls Moderate risk

Philips Medical Systems Nederlands recalls Ingenia Elition S, Ingenia Elition X

Recall date
December 3, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0694-2019
FDA classification
Class II
Brand / firm
Philips Medical Systems Nederlands
Sold / distributed
CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.

Why it was recalled

During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ingenia Elition S, Ingenia Elition X

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