Z-3200-2024Class II

Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images...

Name: Z-3200-2024 Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images...
Creator: Philips North America Llc
Published: 2024-09-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-09-03 / Open, Classified

FDA source

Philips North America Llc began a recall of Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head... on 2024-09-03. FDA classified it as Class II and gives the reason as "Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3200-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-03
Posted: 2024-09-20
Recalling firm: Philips North America LLC
Product: Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
FDA root cause: Under Investigation by firm
Action: Philips issued URGENT Medical Device Correction dated 8/23/24 to US consignees via Fed'x. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: A. Customers can continue using identified systems in accordance with the intended use. B. As a reminder, when using MR systems, follow the warnings listed in the IFU provided with your system: Refer to the warnings listed in the IFU section titled Moving the patient into the magnet bore: " Before starting a scan which initiates tabletop movement, always check that nothing can get caught or hit during tabletop movement. " Check patient, patient extremities, clothing, equipment and positioning aids. Guide cables and intravenous lines " Due care must be taken to ensure that no part of the patient's body, hair, clothing cables or infusion lines can be trapped or injured by any part of the equipment. C. If you experience resistance from the tabletop movement during patient scan, Stop-use immediately and contact your local Philips service representative. D. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. E. Please display attached Advisory with your system(s); ensure the notice is in a place likely to be seen/viewed by operators. F. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt via email to: [email protected]. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. The actions planned by Philips to correct the problem Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit your site to inspect the IRF carrier assembly and provide a correction if necessary (reference FCO78100588). Philips plans to start implementing corrections in Q4 2024. If you need a
Quantity in commerce: 33 units
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Maldives, Mauritius, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam.
Product codes and lots: Model UDI-DI: 782151 N/A; 782119 (01)00884838104129(21); 781358 (01)00884838088115(21); 782107 (01)00884838098336(21); 782136 (01)00884838108608(21) Serial Numbers: 26500 26505 28502 28509 45393 45467 45599 62029 62041 62051 62052 62061 62066 62070 62071 62081 62082 62083 62091 62103 62111 62113 62114 62120 62126 62129 62147 62148 62186 62187 62188 66001 66002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3200-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3193-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3194-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3195-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3196-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3197-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3198-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3199-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3200-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3201-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3202-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3203-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3204-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3205-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)