FDA Medical Device Recalls (openFDA)
Philips North America Llc: Ingenia 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: 781342
- Recall number
- Z-2343-2021
- Recalling firm
- Philips North America Llc
- Product
- Ingenia 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: 781342
- Status
- Terminated
- Initiated
- 2021-07-30
- Posted
- not on file
- Terminated
- 2023-07-25
- Reason
- 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
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 3 units US; 17 units OUS
- 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, serial or model codes
- S/N and UDI: 85275 (01)00884838055339(21)85275; 85278 (01)00884838055339(21)85278; 85394 (01)00884838055339(21)85394. OUS: 85393 (01)00884838055339 85332 (01)00884838055339 85334 (01)00884838055339 85336 (01)00884838055339 85349 (01)00884838055339 85350 (01)00884838055339 85355 (01)00884838055339 85370 (01)00884838055339 85371 (01)00884838055339 85382 (01)00884838055339 85384 (01)00884838055339 85385 (01)00884838055339 85398 (01)00884838055339 85348 (01)00884838055339 85149 (01)00884838055339 85367 (01)00884838055339 85388 (01)00884838055339
- 510(k) numbers
- ["K163116"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3016618143
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28