Recall Z-1847-2024 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America Llc
Ingenia 1.5T S Model Number (REF): 781347
| Date | May 17, 2024 (initiated May 3, 2024) |
| Status | Open, Classified |
| Reason | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire |
| Root cause | Under Investigation by firm |
| Action | Philips issued Urgent Medical Device Correction notifications to customers on 22-Apr-2024 via FedEx . Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: If a smoke/fire alarm is detected: a. Immediately stop scanning and evacuate the patient and staff from the examination room. b. If a developing fire is detected, adhere to established hospital fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency |
| Quantity | 139 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., Apr 10, 2020 |