Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Summary
The FDA issued a Class II for Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78213 by Philips North America Llc. Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire..
Details
Source
Device Recall
External ID
Z-0460-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
Product Description
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Lot/Code Info: 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
Quantity Affected: 566 total
Reason for Recall
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-22
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0460-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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