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Ingenia recallZ-2210-2025 · Philips North America · initiated Jun 30, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Device Design

What the company is doing

On June 30, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users 4.1. When using any affected system identified according to the information in section 3, follow the instructions below. 4.2. Pay particular attention if a scan interruption occurs and a scan abort symbol is encountered, which may appear in the user interface (UI) with the symbols shown in Figure 4 below: Figure 4. Scan Abort Symbols 4.3. When scan aborts occur the symbol is shown and applicable messages are presented in the message box (see Figure 5 and Figure 6 examples) 4.3.1. Check the status of the error messages in the User Interface (UI) screen. Click to expand the message box in case previous messages are hidden, see orange box in Figure 5 and Figure 6 below. If possible, correct the issue that is relevant to the error shown and continue scanning, for example: RF door must be closed while performing scan. Scan aborted. Patient support is moved while scanning, scan stopped. Coil A (or B) failure, coil disconnected? . 4.3.2. If, after a scan abort, one of the following conditions occur five times in a row stop scanning immediately and contact Philips Service to describe the problem: If there is no error message in the message box If the error message meaning is not clear 4.3.3. If the error message Gradient amplifier Rack Fault is received two times in a row, or if the error message Gradient amplifier Rack Fault is preceded or followed by an aborted scan with no message, then stop scanning immediately and contact Philips Service to describe the problem. 4.3.4. If you encounter any of these conditions described in 4.3.2 or 4.3.3 do not attempt any additional/further scans, including without limitation do not attempt any phantom scanning until your system has been checked and released by a Philips Service representative. 4.4. If smoke and/or fire is detected

Recall details

Recall number
Z-2210-2025
Status
Open, Classified
Initiated by the company
Jun 30, 2025
Posted by the FDA
Jul 30, 2025
Recalling firm
Philips North America
Quantity
242 units
Product code
LNH
FDA submissions
K193215, K230972
Distribution
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.

Product description

Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615, (4) None; Serial Numbers: (1) 46001, 46002, 46003, 46004, 46005, 46007, 46008, 46011, 46012, 46013, 46014, 46015, 46016, 46017, 46018, 46019, 46020, 46021, 46023, 46024, 46025, 46026, 46027, 46029, 46030, 46031, 46032, 46033, 46036, 46037, 46039, 46041, 46042, 46044, 46045, 46046, 46048, 46049, 46050, 46052, 46053, 46054, 46055, 46057, 46058, 46059, 46060, 46061, 46065, 46066, 46067, 46068, 46069, 46071, 46075, 46076, 46077, 46078, 46081, 46082, 46083, 46085, 46086, 46088, 46089, 46092, 46093, 46094, 46095, 46097, 46101, 46104, 46107, 46109, 46111, 46119, 46121, (2) 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46207, 46208, 46209, 46211, 46212, 46213, 46214, 46215, 46217, 46218, 46219, 46220, 46222, 46224, 46225, 46226, 46228, 46231, 46233, 46234, 46235, 46237, 46239, 46240, 46241, 46242, 46243, 46245, 46247, 46249, 46250, 46258, 46263, 46265, 46268, 46269, 46270, 46281, 46282, 46286, 46289, 46292, 46297, 46304, 46307, 46310, 46311, 46315, 46316, 46317, 46324, 46325, 46326, 46331, 46338, 46348, 46352, 46353, 46354, 46362, 46363, 46367, 46368, 46375, 46376, 46383, 46384, 46387, 46390, 46394, 61010, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64039, 64045, 64046, (4) 26001, 26002, 26003, 26004, 26005, 26006, 26007, 26008, 26010, 26011, 26012, 26013, 26014, 26015, 26016, 26017, 26018, 26020, 26021, 26022, 26023, 26024, 26026, 26027, 26029, 26030, 26031, 26032, 26034, 26035, 26036, 26037, 26038, 26039, 26040, 26041, 26042, 26043, 26045, 26047, 26049, 26051, 26052, 26053, 26054, 26056, 26058, 26059, 26060, 26061, 26062, 26063, 26064, 26065, 26066, 26067, 26068, 26069, 26073, 26075, 26076, 26082;

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97172).

Sources and updates

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