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Recall Observatory FDA recall evidence

Device product

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

Z-1240-2019

March 25, 2019

Class II

Product summary

Firm
Philips Medical Systems Nederlands
Event
Event 82610
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-1240-2019

Official wording

Reason: 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.

Code information: US Serial Number: 47004 OUS Serial Numbers: 47001, 47002, 48000

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.