CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report

Ingenia Elition S, Magnetic Resonance System recalled

Philips North America is recalling Ingenia Elition S, Magnetic Resonance System, distributed nationwide in the US. The recall was initiated on 12 Mar 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. 781357, 782106; UDI-DI 884838088108, 884838098329; Serial No. 46065, 46071, 46077, 46025, 46224, 46005, 46003, 46001, 46008, 46004, 46007, 46032, 46011, 46012, 46013, 46015, 46016, 46017, 46019, 46021, 46002, 46018, 46020, 46023, 46024, 46046, 46026, 46027, 46029, 46030, 46031, 46033, 46109, 46034, 46036, 46039, 46037, 46052, 46041, 46042, 46045, 46088, 46050, 46048, 46049, 46058, 46053, 46055, 46054, 46061, 46060, 46057, 46014, 46059, 46044, 46067, 46066, 46068, 46069, 46075, 46076, 46078, 46081, 46082, 46084, 46086, 46083, 46085, 46089, 46104, 46094, 46092, 46101, 46093, 46095, 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46107, 46208, 46207, 46209, 46211, 46217, 46213, 46214, 46215, 46218, 46111, 46219, 46220, 46222, 46226, 46258, 46231, 46228, 46233, 46235, 46237, 46239, 46249, 46240, 46241, 46242, 46234, 46243, 46245, 46247, 46119, 46268, 46097, 46282, 46289, 46305, 46304, 46263, 46310, 46121, 46315, 46265, 46269, 46270, 46325, 46324, 46331, 46338, 46352.

Quantity recalled131 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1570-2024
FDA event ID: 94233
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Mar 2024
FDA classified: 17 Apr 2024
Reported: 24 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Mar 2024	Recall initiated by company
17 Apr 2024	Classified by FDA	+36 days
24 Apr 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Patient support table floor plate may be incorrectly installed.

Product as listed by the FDA

Ingenia Elition S, Magnetic Resonance System.

Where it was distributed

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.

Nationwide Georgia

Questions about this recall

Is Ingenia Elition S, Magnetic Resonance System recalled?

Yes. Philips North America recalled Ingenia Elition S, Magnetic Resonance System on 12 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1570-2024.

Why was it recalled?

Patient support table floor plate may be incorrectly installed.

Which lots are affected?

Model No. 781357, 782106; UDI-DI 884838088108, 884838098329; Serial No. 46065, 46071, 46077, 46025, 46224, 46005, 46003, 46001, 46008, 46004, 46007, 46032, 46011, 46012, 46013, 46015, 46016, 46017, 46019, 46021, 46002, 46018, 46020, 46023, 46024, 46046, 46026, 46027, 46029, 46030, 46031, 46033, 46109, 46034, 46036, 46039, 46037, 46052, 46041, 46042, 46045, 46088, 46050, 46048, 46049, 46058, 46053, 46055, 46054, 46061, 46060, 46057, 46014, 46059, 46044, 46067, 46066, 46068, 46069, 46075, 46076, 46078, 46081, 46082, 46084, 46086, 46083, 46085, 46089, 46104, 46094, 46092, 46101, 46093, 46095, 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46107, 46208, 46207, 46209, 46211, 46217, 46213, 46214, 46215, 46218, 46111, 46219, 46220, 46222, 46226, 46258, 46231, 46228, 46233, 46235, 46237, 46239, 46249, 46240, 46241, 46242, 46234, 46243, 46245, 46247, 46119, 46268, 46097, 46282, 46289, 46305, 46304, 46263, 46310, 46121, 46315, 46265, 46269, 46270, 46325, 46324, 46331, 46338, 46352.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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