Recall Z-1441-2018 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Electronics North America Corporation
Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in an
| Date | Apr 18, 2018 (initiated Mar 16, 2018) |
| Status | Terminated |
| Reason | Potential risk for helium gas inside the MR examination room during a magnet quench |
| Root cause | Nonconforming Material/Component |
| Action | On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm. **Action to be Taken by Customer**: During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a mag |
| Quantity | 8,205 units in total |
| Distribution | Worldwide Distribution - US Nationwide; International - Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Chile, China, Colombia, Congo (Democratic Republic o |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.