Ingenia 1.5T Evoluton- 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: 781315
Check against the official notice below — it lists the full affected range.
Philips North America LLC has recalled Ingenia 1.5T Evolution Magnetic Resonance imaging systems used for diagnostic purposes. The recall affects two units distributed in the United States (in Alabama, Arizona, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas, and Virginia) and 16 units distributed outside the US in Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Lebanon, Netherlands, Romania, Russia, Saudi Arabia, Spain, Turkey, Ukraine, and the United Kingdom.
The recalled systems contain an incorrect pressure relief valve rated at 42 psi installed in the magnet assembly instead of the correct 3.75 psi valve. This defect may result in the release of helium gas that could cause injury to users or bystanders. The specific serial numbers and UDI codes for affected units are listed in the recall details. The record does not specify a remedy or recommended 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: 2 units US; 16 units OUS Lot/code info: S/N and UDI: US: 61044 (01)00884838099715(21)61044; 61047 (01)00884838099715(21)61047. OUS: 61028 (01)00884838099715 61008 (01)00884838099715 61025 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61046 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715 61018 (01)00884838099715 61017 (01)00884838099715 61032 (01)00884838099715 61043 (01)00884838099715 61033 (01)00884838099715 61064 (01)00884838099715
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.