Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Summary
The FDA issued a Class II for Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782 by Philips North America. Reason: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system..
Details
Source
Device Recall
External ID
Z-2396-2023
Action Date
2023-08-16
Status
Ongoing
Category
device
Product Description
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Lot/Code Info: Product Number: 781357: UDI-DI: 00884838088108 Serial Numbers: 46119 46111 46109 46107 46104 46101 46097 46095 46094 46093 46092 46089 46088 46086 46085 46084 46083 46082 46081 46078 46077 46076 46075 46071 46069 46068 46067 46066 46065 46061 46060 46059 46058 46057 46055 46054 46053 46052 46050 46049 46048 46046 46045 46044 46042 46041 46039 46037 46036 46034 46033 46032 46031 46030 46029 46027 46026 46025 46024 46023 46021 46020 46019 46018 46017 46016 46015 46014 46013 46012 46011 46008 46007 46005 46004 46003 46002 46001 46121; Product Number 782106: UDI-DI: 00884838098329 Serial Numbers: 61017 61010 46324 46315 46311 46310 46304 46289 46286 46285 46282 46270 46269 46268 46265 46258 46252 46249 46247 46243 46241 46240 46239 46237 46235 46234 46233 46231 46228 46226 46225 46224 46222 46220 46219 46218 46217 46215 46214 46213 46212 46211 46209 46208 46207 46206 46205 46204 46203 46202 46201 46200 46242 46245 46263 46305 46264 46281 46325; Product Number: 782150: UDI-DI: N/A Serial Numbers: 26003 26010 26006 26001
Quantity Affected: 640 total
Reason for Recall
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Distribution
US Nationwide. Global Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-12
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 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America has 126 FDA actions in our database, including 126 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) 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 have FDA actions?
Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2396-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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