—#209926

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

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K193215, K212673, K213516
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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: Philips.Recall@philips.com. 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

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-09-03
Posted by FDA: 2024-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209926. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.