FDA recall Z-1240-2019

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-03-25

Report date

2019-05-08

Termination date

2020-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Best, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1240-2019