Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device

Class II, the middle of FDA’s three classes.

Codes to check against yours

Serial Number Unique Device Identifier (UDI#) Model: 781358 45153 (01)00884838088115(21)45153 45062 (01)00884838088115(21)45062 45107 (01)00884838088115(21)45107 45144 (01)00884838088115(21)45144 45145 (01)00884838088115(21)45145 45142…

FDA’s list runs to 7,592 characters. The first part is shown; the rest is on FDA’s record.

Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People’s Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

These words name no state.

What FDA means by nationwide

The words say it went outside the United States too.

Completed, in FDA’s file.

• The firm began the recall on Aug 11, 2021.
• FDA classified it on Sep 3, 2021.
• FDA’s Enforcement Report published it on Sep 15, 2021.

• Philips North America Llc, of Cambridge, MA.
• Who began it, in FDA’s words: Voluntary: Firm initiated.
• How the firm first told its customers: Letter.

• Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
• Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
• How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
• Whether anyone was hurt or fell ill: the report doesn’t say.
• How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
• FDA’s list of codes runs to 7,592 characters; the first part is shown here, and the rest is on FDA’s record.
• A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.

• U.S. Food and Drug Administration, Device recall enforcement reports.

  Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

• This record in openFDA