Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1240-2019 — 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

U.S. FDA — Device Enforcement · Netherlands · 2019-03-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1240-2019
Date of alert
2019-03-25
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems Nederlands
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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