BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    Recall: Z-1958-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-1958-2026
    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 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    Reason

    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.

    Code Info

    1. Model Number (REF): 781342. UDI: (01)00884838055339(21)71693, (01)00884838055339(21)71581, (01)00884838055339(21)71582, (01)00884838055339(21)71607, (01)00884838055339(21)85216, (01)00884838055339(21)71106, (01)00884838055339(21)71477, (01)00884838055339(21)71512, (01)00884838055339(21)71966, (01)00884838055339(21)71967, (01)00884838055339(21)85147, (01)00884838055339(21)85224, (01)00884838055339(21)85318, (01)00884838055339(21)71462, (01)00884838055339(21)71619, (01)00884838055339(21)85250, (01)00884838055339(21)71002, (01)00884838055339(21)71037, (01)00884838055339(21)71269, (01)00884838055339(21)71841, (01)00884838055339(21)71885, (01)00884838055339(21)71897, (01)00884838055339(21)85126, (01)00884838055339(21)85109, (01)00884838055339(21)71296, (01)00884838055339(21)71188, (01)00884838055339(21)71088, (01)00884838055339(21)71387, (01)00884838055339(21)71799, (01)00884838055339(21)71040, (01)00884838055339(21)71344, (01)00884838055339(21)71583, (01)00884838055339(21)71916, (01)00884838055339(21)71368, (01)00884838055339(21)71756, (01)00884838055339(21)71822, (01)00884838055339(21)71459, (01)00884838055339(21)71022, (01)00884838055339(21)71185, (01)00884838055339(21)71286, (01)00884838055339(21)71378, (01)00884838055339(21)71646, (01)00884838055339(21)71732, (01)00884838055339(21)71612, (01)00884838055339(21)71340, (01)00884838055339(21)71336. Serial Numbers: 71693, 71581, 71582, 71607, 85216, 71106, 71477, 71512, 71966, 71967, 85147, 85224, 85318, 71462, 71619, 85250, 71002, 71037, 71269, 71841, 71885, 71897, 85126, 85109, 71296, 71188, 71088, 71387, 71799, 71040, 71344, 71583, 71916, 71368, 71756, 71822, 71459, 71022, 71185, 71286, 71378, 71646, 71732, 71612, 71340, 71336. 2. Model Number (REF): 781377. UDI: (01)00884838009813(21)42305, (01)00884838009813(21)42097, (01)00884838009813(21)42364, (01)00884838009813(21)42136, (01)00884838009813(21)42237, (01)00884838009813(21)42455, (01)00884838009813(21)42087, (01)00884838009813(21)42401, (01)00884838009813(21)42321, (01)00884838009813(21)42001, (01)00884838009813(21)42036, (01)00884838009813(21)42053, (01)00884838009813(21)42126, (01)00884838009813(21)42400. Serial Numbers: 42305, 42097, 42364, 42136, 42237, 42455, 42087, 42401, 42321, 42001, 42036, 42053, 42126, 42400. 3. Model Number (REF): 782103. UDI: (01)00884838098299(21)85672, (01)00884838098299(21)85673, (01)00884838098299(21)85674, (01)00884838098299(21)85646. Serial Numbers: 85672, 85673, 85674, 85646.

    Distribution

    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.

    Quantity

    64 units