Philips Medical Systems Nederlands recalls Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are…

Recall date

March 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1240-2019

FDA classification

Class II

Brand / firm

Philips Medical Systems Nederlands

Sold / distributed

US Distribution to state of: FL and Internationally to: Switzerland and Germany.

Why it was recalled

Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.

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 Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device