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
Check against the official notice below — it lists the full affected range.
Philips North America has recalled Ingenia Elition X-Magnetic Resonance (MRI) systems used for diagnostic imaging. The recall affects 6 units in the United States and 12 units internationally distributed across multiple states including California, New York, Texas, and Ohio, as well as countries including Canada, Mexico, Australia, United Kingdom, and others. The problem involves a pressure relief valve in the magnet assembly: a 42 psi valve was installed instead of the correct 3.75 psi valve, which may result in the uncontrolled release of helium gas and cause injury.
The specific affected devices are identified by serial numbers and UDI (Unique Device Identifiers) listed in the recall record, including US models numbered 45245, 45247, 45261, 45263, 45264, and 45269. The record does not specify a remedy or action that affected consumers should take.
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: 6 units; 12 OUS Lot/code info: 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;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.