Z-1240-2019Class II

Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR...

Name: Z-1240-2019 Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR...
Creator: Philips Medical Systems Nederlands
Published: 2019-03-25
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2019-03-25 / Terminated / root cause: design

FDA source

Philips Medical Systems Nederlands began a recall of Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic... on 2019-03-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1240-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-25
Posted: 2019-04-27
Terminated: 2020-06-04
Recalling firm: Philips Medical Systems Nederland B.V.
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
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: design
FDA root cause: Device Design
Action: Philips issued an "URGENT - Medical Device Correction" letter on 3/25/2019 via certified mail to its customers. Philips Key Markets are responsible for distributing the letters outside of the U.S. Letter identifies the problem, health risk and actions to be taken. The customers were informed that no action from the customer or user of the device is required, as the Magnet Energization Device (MED) is located in a cabinet in the Technical Room, with the output terminals of the MED located behind locked protective covers. Only qualified servicing personnel have access to this. the Magnet PHILIPS Energization Device (MED) will be replaced by a new version, which does not have this problem. If you need any further information or support concerning this issue, please INFORMATION AND contact your local Philips representative or call the Quality Specialist DI BG Q&R Post Market Surveilla at 678-2960248 or email to: [email protected].
Quantity in commerce: 4 units
Distribution: US Distribution to state of: FL and Internationally to: Switzerland and Germany.
Product codes and lots: US Serial Number: 47004 OUS Serial Numbers: 47001, 47002, 48000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1240-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1240-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26

Product code LNH

K181479Class IIIngenia Ambition S and Ingenia Ambition XPhilips Medical Systems Nederland B.V. / cleared 2018-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)