Philips North America Llc: The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.

Agency Publication Date: June 4, 2021

Affected Products

Product: Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X

REF 781356/UDI-DI 00884838090040 Serial Numbers 47001 47002 47003 47009 47000 47012 47017 47013 47047 47040 47052 47015 47049 47056 47023 47019 47030 47053 47014 47035 47034 (removed from scope as of November 2023) 47020 47048 47080 47032 47057 47041 47072 47075 47091 47219 47184 47058 47258 47215 47197 47004 47026 47006 47007 47018 47027 47011 47037 47039 47029 47038 47043 47022 47044 47070 47062 47071 47054 ***Updated November 2023*** REF 781356/UDI-DI 00884838090040 Serial Numbers 47016 47045 47059 47067 47065 47082 47089 47033 47244 47085 47025 47060 47024 47063 47061 47051 47096 47097 47028 47094 47225 47064 47248 47074 47083 47187 47098 47174 47068 47190 47195 47227 47194 47245 47175 47221 47226 47088 47220 47270 47050 47084 47099 47093 47203 47275 47260 47264 47252 REF 782109/UDI-DI 00884838098350 Serial Numbers 47500, 47519, 47511

Product: Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.

REF 781359/ UDI-DI 00884838090057 Serial numbers: 48000 48001 48003 48004 48009 48005 48015 48017 48020 48011 48022 48012 48014 48028 48026 48037 48023 48043 48019 48160 48144 48180 48112 48052 ***Updated November 2023*** Added Serial Numbers 48051 48010 48038 48018 48039 48027 48122 48046 48036 48047 48133 48056 48169 48148 48154 48055 48128 48194 48173 48134 48040 48155 48186 48035 48181 48188 48198

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87962

Status: Active

Manufacturer: Philips North America Llc

Manufactured In: United States

Units Affected: 2 products (156 MR Systems; 156 MR systems)

Agency Last Updated: November 24, 2023

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Product: Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X

Product: Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.