medical Class II Updated 2021-06-16

Philips North America Llc recalls Ingenia Ambition S - Model Number: 781359 Diagnostic MR sys

Recalled Product

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

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 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
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