Philips North America Llc: Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 7

Hazard

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Details from the source

Reason for recall: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom. Quantity: 509 units Lot/code info: UDI-DI: (1) 782138 (01)00884838108622(21); (2) 782109 (01)00884838098350(21); (3) 781356 (01)00884838090040(21); Serial Number 47194 47040 47092 47091 47048 47195 47345 47361 47050 47209 47246 47247 47293 47254 47275 47019 47049 47200 47356 47357 47197 47270 47013 47014 47015 47053 47065 47082 47099 47268 47274 47000 47002 47003 47017 47020 47024 47035 47047 47056 47058 47074 47078 47089 47097 47192 47225 47337 47226 47227 47341 47307 47364 47365 47372 47284 47350 47057 47075 47081 47088 47174 47175 47188 47193 47288 47052 47059 47072 47085 47184 47187 47211 47252 47262 47304 47328 47342 47384 47064 47244 47219 47220 47298 47094 47329 47096 47207 47283 47190 47264 47309 47034 47202 47315 47332 47367 47385 47016 47269 47382 47352 47012 47021 47221 47276 47297 47313 47314 47271 47281 47001 47032 47041 47248 47255 47258 47301 47311 47272 47306 47009 47023 47030 47080 47083 47189 47215 47222 47230 47231 47242 47245 47286 47299 47302 47310 47312 47004 47006 47007 47011 47018 47022 47025 47026 47027 47028 47029 47033 47037 47038 47039 47043 47044 47045 47051 47054 47060 47061 47062 47063 47066 47067 47068 47070 47071 47084 47090 47093 47095 47098 47177 47183 47185 47196 47198 47199 47203 47204 47205 47206 47208 47210 47216 47233 47237 47251 47253 47260 47278 47279 47280 47282 47289 47290 47291 47292 47294 47303 47305 47316 47322 47323 47324 47325 47330 47331 47333 47335 47336 47338 47339 47340 47344 47346 47347 47348 47351 47353 47370 47371 47377 47378 47380 47387 47173 47077 47657

UPC codes

00884838108622, 00884838098350, 00884838090040

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.