Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
Enforcement
- Recall Number
- Z-1963-2026
- Event ID
- 98779
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 6, 2026
- Initiation Date
- April 14, 2026
- Classification Date
- April 27, 2026
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2296, United States
Description
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
1. Model Number (REF): 781358. UDI: (01)00884838088115(21)45121, (01)00884838088115(21)45148, (01)00884838088115(21)45160, (01)00884838088115(21)45438, (01)00884838088115(21)45034, (01)00884838088115(21)45049, (01)00884838088115(21)45066, (01)00884838088115(21)45090, (01)00884838088115(21)45141, (01)00884838088115(21)45149, (01)00884838088115(21)45170, (01)00884838088115(21)45250, (01)00884838088115(21)45290, (01)00884838088115(21)45085, (01)00884838088115(21)45312, (01)00884838088115(21)45376, (01)00884838088115(21)45122, (01)00884838088115(21)45169, (01)00884838088115(21)45191, (01)00884838088115(21)45192, (01)00884838088115(21)45203, (01)00884838088115(21)45204, (01)00884838088115(21)45207, (01)00884838088115(21)45220, (01)00884838088115(21)45228, (01)00884838088115(21)45229, (01)00884838088115(21)45249, (01)00884838088115(21)45278, (01)00884838088115(21)45279, (01)00884838088115(21)45320, (01)00884838088115(21)45028, (01)00884838088115(21)45195, (01)00884838088115(21)45174, (01)00884838088115(21)45165, (01)00884838088115(21)45382, (01)00884838088115(21)45011, (01)00884838088115(21)45055, (01)00884838088115(21)45075, (01)00884838088115(21)45113, (01)00884838088115(21)45147, (01)00884838088115(21)45152, (01)00884838088115(21)45235, (01)00884838088115(21)45237, (01)00884838088115(21)45245, (01)00884838088115(21)45264, (01)00884838088115(21)45269, (01)00884838088115(21)45277, (01)00884838088115(21)45316, (01)00884838088115(21)45322, (01)00884838088115(21)45337, (01)00884838088115(21)45338, (01)00884838088115(21)45353, (01)00884838088115(21)45398, (01)00884838088115(21)45414, (01)00884838088115(21)45429, (01)00884838088115(21)45051. Serial Numbers: 45121, 45148, 45160, 45438, 45034, 45049, 45066, 45090, 45141, 45149, 45170, 45250, 45290, 45085, 45312, 45376, 45122, 45169, 45191, 45192, 45203, 45204, 45207, 45220, 45228, 45229, 45249, 45278, 45279, 45320, 45028, 45195, 45174, 45165, 45382, 45011, 45055, 45075, 45113, 45147, 45152, 45235, 45237, 45245, 45264, 45269, 45277, 45316, 45322, 45337, 45338, 45353, 45398, 45414, 45429, 45051. 2. Model Number (REF): 782107. UDI: (01)00884838098336(21)45590, (01)00884838098336(21)62158, (01)00884838098336(21)62180, (01)00884838098336(21)62044, (01)00884838098336(21)45567, (01)00884838098336(21)62031, (01)00884838098336(21)62166, (01)00884838098336(21)62184, (01)00884838098336(21)62190, (01)00884838098336(21)62240, (01)00884838098336(21)45519, (01)00884838098336(21)45533, (01)00884838098336(21)62024, (01)00884838098336(21)62047, (01)00884838098336(21)62048, (01)00884838098336(21)62051, (01)00884838098336(21)62052, (01)00884838098336(21)45554, (01)00884838098336(21)62145, (01)00884838098336(21)62146, (01)00884838098336(21)62148, (01)00884838098336(21)45500, (01)00884838098336(21)45501, (01)00884838098336(21)45510, (01)00884838098336(21)45511, (01)00884838098336(21)45514, (01)00884838098336(21)45516, (01)00884838098336(21)45518, (01)00884838098336(21)45589, (01)00884838098336(21)62017, (01)00884838098336(21)62039, (01)00884838098336(21)62073, (01)00884838098336(21)62081, (01)00884838098336(21)62088, (01)00884838098336(21)45521, (01)00884838098336(21)45600, (01)00884838098336(21)45563, (01)00884838098336(21)45570, (01)00884838098336(21)62153, (01)00884838098336(21)62181, (01)00884838098336(21)62182, (01)00884838098336(21)62183. Serial Numbers: 45590, 62158, 62180, 62044, 45567, 62031, 62166, 62184, 62190, 62240, 45519, 45533, 62024, 62047, 62048, 62051, 62052, 45554, 62145, 62146, 62148, 45500, 45501, 45510, 45511, 45514, 45516, 45518, 45589, 62017, 62039, 62073, 62081, 62088, 45521, 45600, 45563, 45570, 62153, 62181, 62182, 62183. 3. Model Number (REF): 782136. UDI: (01)00884838108608(21)28568, (01)00884838108608(21)28503, (01)00884838108608(21)28515, (01)00884838108608(21)28528, (01)00884838108608(21)28577. Serial Numbers: 28568, 28503, 28515, 28528, 28577.
Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.
103 units