FDAClass IIApril 24, 2024

MR 5300 recall

MR 5300, Magnetic Resonance System.

Why was MR 5300 recalled?

Patient support table floor plate may be incorrectly installed.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No. 782110; UDI-DI 884838099364; Serial No. 63029, 63087, 63014, 63103, 63000, 63006, 63007, 63001, 63008, 63010, 63013, 63015, 63021, 63022, 63039, 63023, 63024, 63026, 63025, 63028, 63030, 63031, 63038, 63054, 63041, 63042, 63046, 63043, 63044, 63047, 63049, 63050, 63012, 63051, 63053, 63032, 63057, 63060, 63094, 63064, 63063, 63068, 63079, 63066, 63072, 63071, 63070, 63082, 63074, 63076, 63083, 63202, 63085, 63019, 63086, 63093, 63091, 63090, 63096, 63097, 63165, 63075, 63099, 63104, 63106, 63105, 63108, 63009, 63107, 63109, 63111, 63112, 63119, 63115, 63116, 63127, 63121, 63125, 63069, 63034, 63130, 63036, 63058, 63155, 63144, 63140, 63141, 63146, 63033, 63149, 63151, 63150, 63153, 63154, 63157, 63161, 63080, 63098, 63018, 63166, 63169, 63175, 63176, 63178, 63177, 63191, 63197, 63188, 63183, 63186, 63187, 63198, 63195, 63199, 63262, 63210, 63148, 63223, 63224, 63239, 63228, 63229, 63128, 63261, 63260, 63122, 63243, 63248, 63252, 63027, 63266, 63267, 63268, 63276, 63271, 63283, 63287, 63286, 63306, 63272, 63292, 63309, 63135, 63311, 63078, 63190, 63174, 63201, 63331, 63168, 63139, 63290, 63220, 63288, 63304, 63264, 63138, 63402, 63016, 63270, 63305, 63282, 63285, 63265, 63289, 63303.

Product
MR 5300, Magnetic Resonance System.
Recalling firm
Philips North America Llc
Quantity
166 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.
Recall date
April 24, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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