Recall Z-2344-2021 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America Llc
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
| Date | Jul 30, 2021 |
| Status | Terminated |
| Reason | 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 | 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 a |
| Quantity | 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, Neth |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173451 | Ingenia Elition S and Ingenia Elition X Philips Medical Systems Nederland B.V., Mar 20, 2018 |