Reported Aug 16, 2023 · Ongoing
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Philips North America
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 · 222 Jacobs St · Cambridge, MA · 02141-2296
Is this the product you have?
- Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 78135700884838088108UDI-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 78210600884838098329UDI-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 782150UDI-DI: N/A Serial Numbers: 26003 26010 26006 26001 - Amount recalled
- 640 total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
This product could cause temporary or reversible health problems — stop using it.
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