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Philips North America Llc Recall 88491

Description: Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356

Philips North America Llc Recall 88491 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2422-2021
Event ID88491
Event DescriptionIngenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
Quantity147 units
Recall ReasonWhen using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Device Classification20210915
Device Code InfoSerial Number Unique Device Identifier (UDI#) Model: 781356 47077 (01)00884838090040(21)47077 47194 (01)00884838090040(21)47194 47091 (01)00884838090040(21)47091 47040 (01)00884838090040(21)47040 47092 (01)00884838090040(21)47092 47048 (01)00884838090040(21)47048 47195 N/A 47050 (01)00884838090040(21)47050 47209 (01)00884838090040(21)47209 47247 (01)00884838090040(21)47247 47293 (01)00884838090040(21)47293 47001 (01)00884838090040 47032 (01)00884838090040(21)47032 47041 (01)00884838090040(21)47041 47086 (01)00884838090040(21)47086 47248 (01)00884838090040(21)47248 47255 (01)00884838090040(21)47255 47258 (01)00884838090040(21)47258 47275 (01)00884838090040(21)47275 47002 (01)00884838090040(21)47002 47003 (01)00884838090040(21)47003 47000 (01)00884838090040(21)47000 47017 (01)00884838090040(21)47017 47047 (01)00884838090040(21)47047 47056 (01)00884838090040(21)47056 47035 (01)00884838090040(21)47035 47020 (01)00884838090040(21)47020 47078 (01)00884838090040(21)47078 47089 (01)00884838090040(21)47089 47024 (01)00884838090040(21)47024 47097 (01)00884838090040(21)47097 47225 (01)00884838090040(21)47225 47074 (01)00884838090040(21)47074 47058 (01)00884838090040(21)47058 47192 (01)00884838090040(21)47192 47049 (01)00884838090040(21)47049 47019 (01)00884838090040(21)47019 47012 (01)00884838090040(21)47012 47221 (01)00884838090040(21)47221 47276 (01)00884838090040(21)47276 47297 N/A 47270 (01)00884838090040(21)47270 47197 (01)00884838090040(21)47197 47013 (01)00884838090040(21)47013 47015 (01)00884838090040(21)47015 47053 N/A 47014 N/A 47065 N/A 47082 N/A 47099 N/A 47268 N/A 47009 (01)00884838090040(21)47009 47023 (01)00884838090040(21)47023 47030 (01)00884838090040(21)47030 47080 (01)00884838090040(21)47080 47083 (01)00884838090040(21)47083 47245 (01)00884838090040(21)47245 47215 (01)00884838090040(21)47215 47222 (01)00884838090040(21)47222 47299 (01)00884838090040(21)47299 47227 (01)00884838090040(21)47227 47226 (01)00884838090040(21)47226 47265 (01)00884838090040(21)47265 47284 (01)00884838090040(21)47284 47307 (01)00884838090040(21)47307 47057 (01)00884838090040(21)47057 47075 (01)00884838090040(21)47075 47174 (01)00884838090040(21)47174 47088 (01)00884838090040(21)47088 47175 (01)00884838090040(21)47175 47193 (01)00884838090040(21)47193 47081 (01)00884838090040(21)47081 47188 (01)00884838090040(21)47188 47052 (01)00884838090040(21)47052 47059 (01)00884838090040(21)47059 47085 (01)00884838090040(21)47085 47072 (01)00884838090040(21)47072 47184 (01)00884838090040(21)47184 47187 (01)00884838090040(21)47187 47262 (01)00884838090040(21)47262 47211 (01)00884838090040(21)47211 47252 (01)00884838090040(21)47252 47304 (01)00884838090040(21)47304 47298 (01)00884838090040(21)47298 47094 (01)00884838090040(21)47094 47064 (01)00884838090040(21)47064 47244 (01)00884838090040(21)47244 47219 (01)00884838090040(21)47219 47220 (01)00884838090040(21)47220 47096 (01)00884838090040(21)47096 47190 (01)00884838090040(21)47190 47264 (01)00884838090040(21)47264 47034 (01)00884838090040(21)47034 47202 (01)00884838090040(21)47202 47016 (01)00884838090040(21)47016 47269 (01)00884838090040(21)47269 47271 (01)00884838090040(21)47271 47272 N/A 47004 (01)00884838090040(21)47004 47026 (01)00884838090040(21)47026 47006 (01)00884838090040(21)47006 47007 (01)00884838090040(21)47007 47018 (01)00884838090040(21)47018 47027 (01)00884838090040(21)47027 47011 (01)00884838090040(21)47011 47037 (01)00884838090040(21)47037 47039 (01)00884838090040(21)47039 47029 (01)00884838090040(21)47029 47038 (01)00884838090040(21)47038 47043 (01)00884838090040(21)47043 47054 (01)00884838090040(21)47054 47022 (01)00884838090040(21)47022 47044 (01)00884838090040(21)47044 47028 (01)00884838090040(21)47028 47070 (01)00884838090040(21)47070 47062 (01)00884838090040(21)47062 47033 (01)00884838090040(21)47033 47067 (01)00884838090040(21)47067 47045 (01)00884838090040(21)47045 47060 (01)00884838090040(21)47060 47025 (01)00884838090040(21)47025 47051 (01)00884838090040(21)47051 47063 (01)00884838090040(21)47063 47061 (01)00884838090040(21)47061 47071 (01)00884838090040(21)47071 47066 (01)00884838090040(21)47066 47084 (01)00884838090040(21)47084 47098 (01)00884838090040(21)47098 47095 (01)00884838090040(21)47095 47198 (01)00884838090040(21)47198 47093 (01)00884838090040(21)47093 47177 (01)00884838090040(21)47177 47196 (01)00884838090040(21)47196 47199 (01)00884838090040(21)47199 47203 (01)00884838090040(21)47203 47206 (01)00884838090040(21)47206 47068 (01)00884838090040(21)47068 47183 (01)00884838090040(21)47183 47279 (01)00884838090040(21)47279 47208 (01)00884838090040(21)47208 47260 (01)00884838090040(21)47260 47282 (01)00884838090040(21)47282 47216 (01)00884838090040(21)47216 47185 (01)00884838090040(21)47185 47233 (01)00884838090040(21)47233 47292 (01)00884838090040(21)47292
Center Classification Date20210903
Recall Initiation Date20210811
Recalling FirmPhilips North America Llc
Initial Notification Letter
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