Ingenia 1.5T-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: 781341
Check against the official notice below — it lists the full affected range.
Philips North America has recalled its Ingenia 1.5T-Magnetic Resonance medical imaging system due to an incorrect pressure relief valve installed in the magnet assembly. The system contains a 42 psi pressure relief valve instead of the correct 3.75 psi valve, which may result in the release of helium gas and cause injury. A total of 3 units were distributed in the United States across multiple states including California, New York, Texas, and Ohio, with an additional 24 units distributed internationally across Canada, Mexico, Australia, and various European and Asian countries.
The affected units have been identified by serial numbers and UDI codes, including US units 84344, 87019, and 87231, along with 24 additional units distributed outside the US. The recall notice does not specify a remedy or corrective 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: 3 units US; 24 units OUS Lot/code info: S/N and UDI: 84344 (01)00884838055322(21)84344; 87019 (01)00884838055322(21)87019; 87231 (01)00884838055322(21)87231. OUS: 87171 (01)00884838055322 84943 (01)00884838055322 87142 (01)00884838055322 87249 (01)00884838055322 87252 (01)00884838055322 87195 (01)00884838055322 87129 (01)00884838055322 87136 (01)00884838055322 87175 (01)00884838055322 87196 (01)00884838055322 87197 (01)00884838055322 87235 (01)00884838055322 87187 (01)00884838055322 87212 (01)00884838055322 84572 (01)00884838055322 87116 (01)00884838055322 87152 (01)00884838055322 87161 (01)00884838055322 87237 (01)00884838055322 87244 (01)00884838055322 87090 (01)00884838055322 87093 (01)00884838055322 87259 (01)00884838055322 87209 (01)00884838055322
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.