Recall Z-1435-2018 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Electronics North America Corporation
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-secti
| 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
| K052013 | ACHIEVA 1.5T & INERA 1.5T FAMILY Philips Medical Systems Nederland B.V., Aug 2, 2005 |