Recall Z-0389-2024 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America Llc
Achieva 1.5T
| Date | Nov 21, 2023 (initiated Oct 23, 2023) |
| Status | Open, Classified |
| Reason | Potential component failure in the Gradient Coil could product smoke and/or fire. |
| Root cause | Under Investigation by firm |
| Action | The firm mailed URGENT Medical Device Correction Notices dated 10/23/2023 to consignees to notify them of this recall event. Consignees are instructed to identify if they possess any affected devices in their inventory and to follow the provided instructions for when scan aborts occur to prevent the failure mode associated with this recall event. Consignees are to stop the scan immediately and contact Philips Service if any of the failure situations outlined in the notice occur during a scan. Consignees are asked to complete and return the provided response form to Philips no later than 30 day |
| Quantity | 520 units |
| Distribution | Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, I |
| 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 |
| K052078 | ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES Philips Medical Systems Nederland B.V., Sep 7, 2005 |
| K063559 | ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 Philips Medical Systems, Jan 4, 2007 |
| K162931 | Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 Philips Medical Systems Nederland B.V., Jan 6, 2017 |
| K173079 | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 Philips Medical Systems Nederland B.V., Apr 4, 2018 |