Z-2344-2021Class II

Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The...

Name: Z-2344-2021 Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The...
Creator: Philips North America Llc
Published: 2021-07-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-07-30 / Terminated / root cause: manufacturing process

FDA source

Philips North America Llc began a recall of Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images... on 2021-07-30. FDA classified it as Class II and gives the reason as "Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2344-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-30
Posted: 2021-08-25
Terminated: 2023-07-25
Recalling firm: Philips North America LLC
Product: Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781358
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips North America issued U.S. customers letters via certified mail using a 3rd Party service. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall , health risk and action to take: The Philips Ingenia 1.5T, Ingenia 1.5T Evolution, Ingenia 3.0T, and Ingenia Elition X MR systems can continue to fulfill clinical use as normal. However, in case of technical problems related to off cooling of the magnet, magnet pressure or Helium boil-off, please stop use and contact your local Philips service representative immediately and reference FCO78100530. A Philips Field Service Engineer (FSE) will contact you to schedule an on-site visit to resolve the issue by inspecting the potentially affected system(s) to confirm if the non-conforming pressure relief (42 psi) has been installed (reference FCO78100530). If your system has a 42 psi valve, the Phillips FSE will replace the valve with the correct 3.75 psi valve. you need any further information or support concerning this issue, please contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO78100530.
Quantity in commerce: 6 units; 12 OUS
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom.
Product codes and lots: S/N and UDI: US: 45245 (01)00884838088115(21)45245; 45247 (01)00884838088115(21)45247; 45261 (01)00884838088115(21)45261; 45263 (01)00884838088115(21)45263; 45264 (01)00884838088115(21)45264; 45269 (01)00884838088115(21)45269; OUS: 45215 (01)00884838088115; 45284 (01)00884838088115; 45253 (01)00884838088115; 45313 (01)00884838088115; 45265 (01)00884838088115; 45297 (01)00884838088115; 45218 (01)00884838088115; 45272 (01)00884838088115; 45281 (01)00884838088115; 45231 (01)00884838088115; 45278 (01)00884838088115; 45279 (01)00884838088115; 45245 (01)00884838088115; 45247 (01)00884838088115;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2344-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2341-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-25
Z-2342-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-25
Z-2343-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-25
Z-2344-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-25
Z-2345-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-25
Z-2346-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-25
Z-2347-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-25

Product code LNH

K173451Class IIIngenia Elition S and Ingenia Elition XPhilips Medical Systems Nederland B.V. / cleared 2018-03-20

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)