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Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136

FDA Recall #Z-0460-2023 — Class II — November 22, 2022

Recall #Z-0460-2023 Date: November 22, 2022 Classification: Class II Status: Ongoing

Product Description

Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136

Reason for Recall

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

Recalling Firm

Philips North America Llc — Cambridge, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

566 total

Distribution

US Nationwide.

Code Information

Model 781358: UDI-DI: 00884838088115; Serial Numbers: 45002 45051 45075 45108 45133 45164 45243 45269 45337 45356 45010 45053 45086 45112 45147 45178 45245 45296 45338 45357 45011 45054 45087 45113 45150 45179 45247 45321 45343 45364 45024 45060 45089 45124 45152 45194 45252 45322 45353 45395 45027 45068 45099 45132 45161 45238 45263 45335 45355 45414 45026 45055 45082 45100 45235 45237 45264 45315 45398 45423 45032 45078 45092 45146 45236 45261 45277 45316 45399 45429 45035; Model Number 782107: UDI-DI: 00884838098336; Serial Numbers: 45563 45570; Model Number 782119: UDI-DI: 00884838104129; Serial Numbers: Included in Letter but No Devices Distributed in US Model Number 782136: UDI-DI: 00884838108608; Serial Numbers: Included in Letter but No Devices Distributed in US

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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