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)
Enforcement
- Recall Number
- Z-2345-2021
- Event ID
- 88461
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- September 1, 2021
- Initiation Date
- July 30, 2021
- Classification Date
- August 25, 2021
- Termination Date
- July 25, 2023
- Address
- 222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States
Description
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)
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
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
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.
11 units