Recall Z-1550-2024 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America Llc
Achieva 1.5T, Magnetic Resonance System.
| Date | Apr 17, 2024 (initiated Mar 12, 2024) |
| Status | Open, Classified |
| Reason | Patient support table floor plate may be incorrectly installed. |
| Root cause | Process design |
| Action | Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative |
| Quantity | 1,921 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica |
| 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 |