Reported Dec 14, 2022 · Ongoing
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
Philips Ingenia Elition X MR SystemModel Numbers 781358782107782119782136
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Barcodes Product as published 78135800884838088115UDI-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 78210700884838098336UDI-DI: 00884838098336 — Serial Numbers: 45563 45570 78211900884838104129UDI-DI: 00884838104129 78213600884838108608Serial Numbers: Included in Letter but No Devices Distributed in US : UDI-DI: 00884838108608 — Serial Numbers: Included in Letter but No Devices Distributed in US - Amount recalled
- 566 total
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
This product could cause temporary or reversible health problems — stop using it.
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