medical Class II Updated 2021-06-16

Philips North America Llc recalls Ingenia Ambition X - Model Number: 781356, Diagnostic MR sy

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT
Lot/Code Info: 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
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