Z-3201-2024Class II

MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or...

Name: Z-3201-2024 MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or...
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 MR 5300 - 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... 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-3201-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-03
Posted: 2024-09-20
Recalling firm: Philips North America LLC
Product: MR 5300 - 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: 782110
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: 68 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: UDI-DI: (01)00884838099364(21) Serial Numbers: 63027 63035 63039 63066 63068 63070 63076 63078 63083 63084 63086 63092 63094 63096 63097 63103 63104 63106 63109 63112 63113 63115 63122 63123 63125 63128 63130 63132 63135 63137 63140 63141 63142 63143 63144 63146 63148 63149 63150 63151 63152 63154 63157 63160 63161 63168 63169 63172 63174 63177 63178 63183 63186 63190 63191 63193 63197 63201 63203 63211 63229 63238 63248 63263 63272 63288 63367 63370

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3201-2024
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)