CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report

Evolution Upgrade 5T recalled by Philips North America

Philips North America is recalling Evolution Upgrade 5T, distributed nationwide in the US. The recall was initiated on 30 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers (REF): (1) 782116, (2) 782148; UDI-DI: (1) 00884838099722, (2) 00884838108714; Serial Numbers: (1) 41017, 41024, 41025, 41041, 41042, 41047, 41051, 41080, 41089, 41130, 41139, 41143, 41144, 41179, 41189, 41196, 41226, 41229, 41235, 41286, 41287, 41295, 41311, 41327, 41344, 41349, 41367, 41413, 41424, 41432, 41433, 41457, 41491, 41497, 41520, 41527, 41568, 70068, 70093, 70099, 70190, 70202, 70205, 70260, 70284, 70589, 70630, 70696, 70949, 70995, 70996, 81021, 81073, 84370, 84741, (2) 41011, 41031, 41182, 41244, 41277, 41284, 41334, 41392, 41427, 41446, 41464, 41488, 41523, 41534, 41547, 70067, 70289, 70452, 70454, 70473, 70590, 70596, 70622, 70644, 70652, 70742, 70769, 70803, 70829, 70966, 70980, 70983, 84102, 84109, 84368, 84435, 84630, 84825,

Quantity recalled93 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-2202-2025
FDA event ID: 97172
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jun 2025
FDA classified: 30 Jul 2025
Reported: 6 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

30 Jun 2025	Recall initiated by company
30 Jul 2025	Classified by FDA	+30 days
6 Aug 2025	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

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.

Nationwide Georgia

Questions about this recall

Is Evolution Upgrade 5T recalled?

Yes. Philips North America recalled Evolution Upgrade 5T on 30 Jun 2025. The recall is Class II and its status is Ongoing. Recall number Z-2202-2025.

Why was it recalled?

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

Which lots are affected?

Model Numbers (REF): (1) 782116, (2) 782148; UDI-DI: (1) 00884838099722, (2) 00884838108714; Serial Numbers: (1) 41017, 41024, 41025, 41041, 41042, 41047, 41051, 41080, 41089, 41130, 41139, 41143, 41144, 41179, 41189, 41196, 41226, 41229, 41235, 41286, 41287, 41295, 41311, 41327, 41344, 41349, 41367, 41413, 41424, 41432, 41433, 41457, 41491, 41497, 41520, 41527, 41568, 70068, 70093, 70099, 70190, 70202, 70205, 70260, 70284, 70589, 70630, 70696, 70949, 70995, 70996, 81021, 81073, 84370, 84741, (2) 41011, 41031, 41182, 41244, 41277, 41284, 41334, 41392, 41427, 41446, 41464, 41488, 41523, 41534, 41547, 70067, 70289, 70452, 70454, 70473, 70590, 70596, 70622, 70644, 70652, 70742, 70769, 70803, 70829, 70966, 70980, 70983, 84102, 84109, 84368, 84435, 84630, 84825,

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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