Ingenia CX 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: 78127 (OUS)
Check against the official notice below — it lists the full affected range.
Philips North America LLC is recalling 11 Ingenia CX 3.0T magnetic resonance imaging systems that were distributed worldwide, including across numerous U.S. states and countries such as Canada, Mexico, Australia, and several European and Asian nations. The systems contain an incorrectly installed pressure relief valve rated at 42 psi instead of the correct 3.75 psi valve in the magnet assembly, which may result in the release of helium gas and cause injury.
The affected units can be identified by their serial numbers and UDI codes, which range from S/N 78189 to S/N 78326. The source document does not specify a remedy or corrective 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: 11 units Lot/code info: S/N and UDI: 78189 (01)00884838068452; 78272 (01)00884838068452; 78294 (01)00884838068452; 78295 (01)00884838068452; 78332 (01)00884838068452; 78335 (01)00884838068452; 78340 (01)00884838068452; 78345 (01)00884838068452; 78249 (01)00884838068452; 78324 (01)00884838068452; 78326 (01)00884838068452
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.