Ingenia 3.0T-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: 781342
Check against the official notice below — it lists the full affected range.
Philips North America is recalling Ingenia 3.0T Magnetic Resonance diagnostic imaging systems due to an incorrect pressure relief valve installed in the magnet assembly. The devices contain a 42 psi valve instead of the correct 3.75 psi valve, which may cause helium gas to be released and potentially injure people. A total of 3 units were distributed in the United States across Alabama, Arizona, Arkansas, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas, and Virginia, while 17 units were distributed outside the US in countries including Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Lebanon, the Netherlands, Romania, Russia, Saudi Arabia, Spain, Turkey, Ukraine, and the United Kingdom.
The specific affected units are identified by serial numbers and UDI codes provided in the recall documentation. The source does not specify a remedy or what affected consumers should do.
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: 3 units US; 17 units OUS Lot/code info: S/N and UDI: 85275 (01)00884838055339(21)85275; 85278 (01)00884838055339(21)85278; 85394 (01)00884838055339(21)85394. OUS: 85393 (01)00884838055339 85332 (01)00884838055339 85334 (01)00884838055339 85336 (01)00884838055339 85349 (01)00884838055339 85350 (01)00884838055339 85355 (01)00884838055339 85370 (01)00884838055339 85371 (01)00884838055339 85382 (01)00884838055339 85384 (01)00884838055339 85385 (01)00884838055339 85398 (01)00884838055339 85348 (01)00884838055339 85149 (01)00884838055339 85367 (01)00884838055339 85388 (01)00884838055339
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.