Recall Z-1433-2018 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Electronics North America Corporation
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Ach
| 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 |