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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenia 3.0T CX

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 Class 2 Device Recall Ingenia 3.0T CXsee related information
Date Initiated by FirmJanuary 03, 2024
Date PostedFebruary 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0951-2024
Recall Event ID 93787
510(K)NumberK213516 
Product Classification System, nuclear magnetic resonance spectroscopic - Product Code LNI
ProductIngenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Code Information a. Model No. 781271; UDI-DI 00884838068452. b. Model No. 782105; UDI-DI 00884838098312. All units affected
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information ContactCustomer Care Solution Center
800-722-9377
Manufacturer Reason
for Recall		The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
FDA Determined
Cause 2		Process control
ActionOn January 4, 2024, the firm began notification of affected customers via URGENT Medical Device Correction letters. Customers were provided with precautions to take when using the device, including inspection of the QBC seal for separation. If the QBC seal is found to be loose, or becomes loose during a patient scan, customers should immediately stop use and contact their local Philips service representative. Customers should also ensure that all users of the device are aware of the issue and retain the letter with affected systems until a solution is installed. Philips will contact customers to schedule a time for a Field Service Engineer (FSE) to visit your site and replace your system's QBC Seal. Philips plans to start implementing corrections in Q3 2024. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377). Revision B of the URGENT Medical Device Correction letter was distributed to the additional US consignees on 24-Mar-2025. It was later identified that UMDC Rev B contained three MR systems with a 70cm bore (Ingenia 1.5T: 781341, Ingenia 3.0T: 781377, Ingenia Ambition X: 782109) which were incorrectly included, as the scope of this field action is MR systems with 60cm bore. The URGENT Medical Device Correction letter was updated to Rev C to remove these systems. Revision C of the UMDC was distributed to the additional US consignees on 09-Apr-2025.
Quantity in Commerce1 US; 347 OUS
DistributionWorldwide - US Nationwide distribution.
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 = LNI
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