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
This recall has been terminated (originally issued July 30, 2021).
- Company
- Philips North America Llc
- Recall Initiated
- July 30, 2021
- Terminated
- July 25, 2023
- Recall Number
- Z-2342-2021
- Quantity
- 3 units US; 24 units OUS
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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.
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
Root Cause
Nonconforming Material/Component
Action Taken
Philips North America issued U.S. customers letters via certified mail using a 3rd Party service. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall , health risk and action to take: The Philips Ingenia 1.5T, Ingenia 1.5T Evolution, Ingenia 3.0T, and Ingenia Elition X MR systems can continue to fulfill clinical use as normal. However, in case of technical problems related to off cooling of the magnet, magnet pressure or Helium boil-off, please stop use and contact your local Philips service representative immediately and reference FCO78100530. A Philips Field Service Engineer (FSE) will contact you to schedule an on-site visit to resolve the issue by inspecting the potentially affected system(s) to confirm if the non-conforming pressure relief (42 psi) has been installed (reference FCO78100530). If your system has a 42 psi valve, the Phillips FSE will replace the valve with the correct 3.75 psi valve. you need any further information or support concerning this issue, please contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO78100530.