Class 2 Device Recall Ingenia 1.5T CX (2024)

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Class 2 Device Recall Ingenia 1.5T CX

Date Initiated by Firm	March 12, 2024
Date Posted	April 17, 2024
Recall Status1	Open3, Classified
Recall Number	Z-1564-2024
Recall Event ID	94233
510(K)Number	K193215
Product Classification	System, nuclear magnetic resonance imaging - Product Code LNH
Product	Ingenia 1.5T CX, Magnetic Resonance System.
Code Information	Model No. 781261, 781262; UDI-DI 884838068438; Serial No. Serial Number, 77000, 77002, 77001, 77004, 77007, 77008, 77010, 77016, 77019, 77030, 77031, 77043, 77032, 77033, 77041, 77034, 77035, 77036, 77037, 77038, 77039, 77040, 77042, 77044, 77046, 77091, 77047, 77048, 77049, 77050, 77053, 77054, 77059, 77051, 77055, 77056, 77052, 77057, 77058, 77060, 77062, 77063, 77061, 77065, 77069, 77068, 77067, 77066, 77070, 77072, 77159, 77127, 77171, 77071, 77074, 77075, 77081, 77094, 77078, 77087, 77092, 77083, 77084, 77118, 77086, 77085, 77088, 77090, 77093, 77097, 77100, 77101, 77103, 77105, 77106, 77107, 77109, 77111, 77110, 77112, 77113, 77114, 77115, 77117, 77119, 77120, 77121, 77122, 77128, 77130, 77123, 77126, 77125, 77124, 77129, 77141, 77138, 77135, 77134, 77136, 77139, 77137, 77131, 77045, 77143, 77150, 77144, 77147, 77151, 77154, 77155, 77157, 77156, 77158, 77160, 77161, 77162, 77166, 77167, 77169, 77168, 77172, 77177, 77178, 77179, 77180, 77181, 77182, 77183, 77185, 77187, 77188, 77190, 77191, 77193, 77194, 77195, 77196, 77198, 77201, 77199, 77203, 77202.
Recalling Firm/ Manufacturer	Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
For Additional Information Contact	Customer Care Solution Center 1-800-722-9377
Manufacturer Reason for Recall	Patient support table floor plate may be incorrectly installed.
FDA Determined Cause 2	Process design
Action	Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to pd.cnr@philips.com.
Quantity in Commerce	143 units
Distribution	Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.
Total Product Life Cycle	TPLC 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) Database	510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland BV

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