Recall Z-1240-2019— Philips Medical Systems Nederlands

Name: FDA recall Z-1240-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-25

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Nederlands, initiated 2019-03-25, terminated 2020-06-04. It names one FDA 510(k) clearance: K181479. 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: 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..

Recalling firm: Philips Medical Systems Nederlands
Classification: Class II
Status: Terminated
Initiated: 2019-03-25
Terminated: 2020-06-04
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K181479 — Ingenia Ambition S and Ingenia Ambition XPhilips Medical Systems Nederland B.V.·cleared 2018-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.