Ingenia Elition S-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: 781357 (OUS)
Check against the official notice below — it lists the full affected range.
Philips North America LLC is recalling seven Ingenia Elition S-Magnetic Resonance Medical Electrical Systems, which are diagnostic imaging devices used to produce cross-sectional and spectroscopic images. The recalled units contain an incorrectly installed pressure relief valve rated at 42 psi instead of the correct 3.75 psi valve in the magnet assembly. This defect may cause unintended helium gas release that could result in injury.
The affected devices were distributed worldwide, including throughout the United States in Alabama, Arizona, Arkansas, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas, and Virginia, as well as in Canada, Mexico, and multiple other countries. The specific units involved are identified by their serial numbers and UDI codes listed in the recall notice. The source document does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 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. Quantity: 7 units Lot/code info: S/N and UDI: 46083 (01)00884838088108; 46084 (01)00884838088108; 46086 (01)00884838088108; 46054 (01)00884838088108; 46058 (01)00884838088108; 46082 (01)00884838088108; 46061 (01)00884838088108;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.