Philips North America Llc: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

Agency Publication Date: December 8, 2022

Affected Products

Product: Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137

Model 781357: UDI-DI: 00884838088108; Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071; Model 782106: UDI-DI: 00884838098329; Serial Numbers: 46224 46225 46265 46269 46311; Model Number 782137: UDI-DI: 00884838108615; Serial Numbers: Included in Letter but No Devices Distributed in the US.

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

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

Product: Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US.

Product: Philips MR 7700 System, Model Number 782120

Model 782120: UDI-DI: 00884838104112; Serial Numbers: 65005 65006 65007 65008

Product: Philips Upgrade to MR 7700 System, Model Number 782130

Model 782120: UDI-DI: 00884838104402; Serial Numbers: 45298 45301

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91195

Status: Active

Manufacturer: Philips North America Llc

Manufactured In: United States

Units Affected: 4 products (566 total)

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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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.