Recall Z-2419-2021 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America Llc
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358
| Date | Aug 11, 2021 |
| Status | Completed |
| Reason | When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment |
| Root cause | Device Design |
| Action | Philips notified U.S. customers an Urgent Medical Device Correction letter on 8/11/21. Letter states reason for recall, health risk and action to take: Philips advises that customers continue to utilize the primary motorized function for the MR system since the identified issue with the HDU does not occur in the motorized mode. If you utilize the manual function and it is not functioning properly, then you must perform table movement using the motorized function. A Philips Field Service Engineer (FSE) will perform a HDU during the next scheduled preventive maintenance visit. If the issue is de |
| Quantity | 228 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173451 | Ingenia Elition S and Ingenia Elition X Philips Medical Systems Nederland B.V., Mar 20, 2018 |