| Class 2 Device Recall Philips | |
Date Initiated by Firm | September 03, 2024 |
Date Posted | September 20, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-3197-2024 |
Recall Event ID |
95289 |
510(K)Number | K193215 K212673 K213516 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product | Ingenia Ambition S - 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) 782108
2) 781359
3) 782133 |
Code Information |
Model UDI-DI:
782108 (01)00884838098343(21);
781359 (01)00884838090057(21).
782133 N/A
Serial Numbers:
27506
27508
27509
27512
27514
27515
27516
27517
27518
27519
27520
27523
27524
27525
27526
27528
27531
48146
48164
48550
48556
48588
48589
48608
48612
48627
48648
48661
48662
48663
48664
48665
48666
48667
48669
48672
48679
48686
48688
48694
48696
48697
48698
48699
48700
48707
48708
48710
48714
48715
48721
48725
48726
48728
48729
48738
48744
48749
48754
48800
48804
48810
48813
48833
|
Recalling Firm/ Manufacturer |
Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
|
For Additional Information Contact | Customer 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 |
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: 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 Commerce | 64 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.
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LNH 510(K)s with Product Code = LNH 510(K)s with Product Code = LNH
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