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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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 Class 2 Device Recall Philipssee related information
Date Initiated by FirmSeptember 03, 2024
Date PostedSeptember 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3200-2024
Recall Event ID 95289
510(K)NumberK193215 K212673 K213516 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIngenia 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
Code Information 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
Recalling Firm/
Manufacturer
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactCustomer Care Solution Center
800-722-9377
Manufacturer 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 Determined
Cause 2
Under Investigation by firm
ActionPhilips 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
Quantity in Commerce33 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
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