Ingenia 3.0T CX-a 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: 781271
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number Unique Device Identifier (UDI#) Model: 781271 78121 (01)00884838068452(21)78121 78150 (01)00884838068452(21)78150 78157 (01)00884838068452(21)78157 78096 N/A 78208 (01)00884838068452(21)78208 78094 N/A 78012 N/A 78074 N/A 78154 (01)00884838068452(21)78154 78161 N/A 78172 (01)00884838068452(21)78172 78170 (01)00884838068452(21)78170 78182 (01)00884838068452(21)78182 78183 (01)00884838068452(21)78183 78205 (01)00884838068452(21)78205 78196 (01)00884838068452(21)78196 78171 (01)00884838068452(21)78171 78213 (01)00884838068452(21)78213 78221 (01)00884838068452(21)78221 78210 (01)00884838068452(21)78210 78212 (01)00884838068452(21)78212 78233 (01)00884838068452(21)78233 78190 (01)00884838068452(21)78190 78198 (01)00884838068452(21)78198 78216 (01)00884838068452(21)78216 78225 (01)00884838068452(21)78225 78238 N/A 78242 (01)00884838068452(21)78242 78173 (01)00884838068452(21)78173 78251 (01)00884838068452(21)78251 78250 (01)00884838068452(21)78250 78241 (01)00884838068452(21)78241 78235 (01)00884838068452(21)78235 78262 (01)00884838068452(21)78262 78253 (01)00884838068452(21)78253 78244 (01)00884838068452(21)78244 78252 (01)00884838068452(21)78252 78256 (01)00884838068452(21)78256 78263 (01)00884838068452(21)78263 78257 N/A 78266 (01)00884838068452(21)78266 78267 (01)00884838068452(21)78267 78269 (01)00884838068452(21)78269 78265 (01)00884838068452(21)78265 78270 (01)00884838068452(21)78270 78284 (01)00884838068452(21)78284 78281 (01)00884838068452(21)78281 78289 (01)00884838068452(21)78289 78293 (01)00884838068452(21)78293 78271 (01)00884838068452(21)78271 78218 (01)00884838068452(21)78218 78291 (01)00884838068452(21)78291 78283 (01)00884838068452(21)78283 78273 (01)00884838068452(21)78273 78305 (01)00884838068452(21)78305 78268 (01)00884838068452(21)78268 78282 (01)00884838068452(21)78282 78279 (01)00884838068452(21)78279 78292 (01)00884838068452(21)78292 78309 (01)00884838068452(21)78309 78288 (01)00884838068452(21)78288 78314 (01)00884838068452(21)78314 78306 (01)00884838068452(21)78306 78319 (01)00884838068452(21)78319 78320 (01)00884838068452(21)78320 78307 (01)00884838068452(21)78307 78296 (01)00884838068452(21)78296 78280 (01)00884838068452(21)78280 78313 (01)00884838068452(21)78313 78317 (01)00884838068452(21)78317 78321 (01)00884838068452(21)78321 78322 (01)00884838068452(21)78322 78316 (01)00884838068452(21)78316 78310 (01)00884838068452(21)78310 78308 (01)00884838068452(21)78308 78312 (01)00884838068452(21)78312 78240 (01)00884838068452(21)78240 78329 (01)00884838068452(21)78329 78272 (01)00884838068452(21)78272 78189 (01)00884838068452(21)78189 78330 (01)00884838068452(21)78330 78332 (01)00884838068452(21)78332 78334 (01)00884838068452(21)78334 78340 (01)00884838068452(21)78340 78243 (01)00884838068452(21)78243 78294 (01)00884838068452(21)78294 78335 (01)00884838068452(21)78335 78345 (01)00884838068452(21)78345 78295 (01)00884838068452(21)78295 78333 (01)00884838068452(21)78333 78342 (01)00884838068452(21)78342 78341 (01)00884838068452(21)78341 78327 (01)00884838068452(21)78327 78347 (01)00884838068452(21)78347 78224 (01)00884838068452(21)78224 78030 N/A 78036 N/A 78059 N/A 78156 (01)00884838068452(21)78156 78249 (01)00884838068452(21)78249 78080 (01)00884838068452(21)78080 78078 (01)00884838068452(21)78078 78098 (01)00884838068452(21)78098 78003 N/A 78017 N/A 78065 N/A 78070 N/A 78081 N/A 78076 N/A 78087 N/A 78101 (01)00884838068452(21)78101 78097 (01)00884838068452(21)78097 78104 (01)00884838068452(21)78104 78099 (01)00884838068452(21)78099 78107 (01)00884838068452(21)78107 78126 (01)00884838068452(21)78126 78149 (01)00884838068452(21)78149 78151 (01)00884838068452(21)78151 78181 N/A 78219 (01)00884838068452(21)78219 78206 (01)00884838068452(21)78206 78264 (01)00884838068452(21)78264 78063 N/A 78064 N/A 78106 (01)00884838068452(21)78106 78187 (01)00884838068452(21)78187 78000 N/A 78005 N/A 78007 N/A 78009 N/A 78016 N/A 78015 N/A 78018 N/A 78023 N/A 78019 N/A 78021 N/A 78027 N/A 78010 N/A 78029 N/A 78031 N/A 78025 N/A 78033 N/A 78032 N/A 78038 N/A 78035 N/A 78039 N/A 78040 N/A 78045 N/A 78043 N/A 78042 N/A 78049 N/A 78048 N/A 78050 N/A 78051 N/A 78062 N/A 78068 (01)00884838068452(21)78068 78067 N/A 78072 (01)00884838068452(21)78072 78084 N/A 78089 (01)00884838068452(21)78089 78082 N/A 78083 (01)00884838068452(21)78083 78091 (01)00884838068452(21)78091 78095 (01)00884838068452(21)78095 78088 (01)00884838068452(21)78088 78100 (01)00884838068452(21)78100 78111 N/A 78115 (01)00884838068452(21)78115 78117 (01)00884838068452(21)78117 78113 (01)00884838068452(21)78113 78114 (01)00884838068452(21)78114 78109 (01)00884838068452(21)78109 78132 (01)00884838068452(21)78132 78127 (01)00884838068452(21)78127 78133 (01)00884838068452(21)78133 78139 (01)00884838068452(21)78139 78140 (01)00884838068452(21)78140 78129 (01)00884838068452(21)78129 78147 (01)00884838068452(21)78147 78148 (01)00884838068452(21)78148 78145 (01)00884838068452(21)78145 78155 (01)00884838068452(21)78155 78203 (01)00884838068452(21)78203 78199 (01)00884838068452(21)78199 78207 (01)00884838068452(21)78207 78222 (01)00884838068452(21)78222 78223 (01)00884838068452(21)78223 78214 (01)00884838068452(21)78214 78011 N/A 78014 N/A 78013 N/A 78028 N/A 78034 N/A 78044 N/A 78047 N/A 78046 N/A 78073 N/A 78058 N/A 78071 (01)00884838068452(21)78071 78086 N/A 78075 N/A 78066 N/A 78060 (01)00884838068452(21)78060 78092 (01)00884838068452(21)78092 78102 (01)00884838068452(21)78102 78077 (01)00884838068452(21)78077 78110 (01)00884838068452(21)78110 78112 (01)00884838068452(21)78112 78103 (01)00884838068452(21)78103 78120 (01)00884838068452(21)78120 78122 (01)00884838068452(21)78122 78123 (01)00884838068452(21)78123 78128 (01)00884838068452(21)78128 78118 (01)00884838068452(21)78118 78135 (01)00884838068452(21)78135 78142 (01)00884838068452(21)78142 78141 (01)00884838068452(21)78141 78158 (01)00884838068452(21)78158 78162 (01)00884838068452(21)78162 78165 (01)00884838068452(21)78165 78167 (01)00884838068452(21)78167 78138 (01)00884838068452(21)78138 78164 (01)00884838068452(21)78164 78166 (01)00884838068452(21)78166 78175 (01)00884838068452(21)78175 78180 (01)00884838068452(21)78180 78186 (01)00884838068452(21)78186 78188 (01)00884838068452(21)78188 78137 (01)00884838068452(21)78137 78195 (01)00884838068452(21)78195 78197 (01)00884838068452(21)78197 78209 (01)00884838068452(21)78209 78193 (01)00884838068452(21)78193 78201 (01)00884838068452(21)78201 78215 (01)00884838068452(21)78215 78217 (01)00884838068452(21)78217 78202 (01)00884838068452(21)78202 78232 (01)00884838068452(21)78232 78194 (01)00884838068452(21)78194 78227 (01)00884838068452(21)78227 78234 (01)00884838068452(21)78234 78255 (01)00884838068452(21)78255 78254 (01)00884838068452(21)78254 78247 (01)00884838068452(21)78247 78259 (01)00884838068452(21)78259 78239 (01)00884838068452(21)78239 78260 (01)00884838068452(21)78260 78261 (01)00884838068452(21)78261 78287 (01)00884838068452(21)78287 78286 (01)00884838068452(21)78286 78299 (01)00884838068452(21)78299 78290 (01)00884838068452(21)78290 78298 (01)00884838068452(21)78298 78297 (01)00884838068452(21)78297 78229 (01)00884838068452(21)78229 78277 (01)00884838068452(21)78277 78326 (01)00884838068452(21)78326 78337 (01)00884838068452(21)78337 78324 (01)00884838068452(21)78324 78336 (01)00884838068452(21)78336 78004 N/A 78008 N/A 78053 N/A 78026 N/A 78022 N/A
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips North America Llc
- Reason for Recall:
- When 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
Ingenia 3.0T CX-a 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: 781271
Product Codes/Lot Numbers:
Serial Number Unique Device Identifier (UDI#) Model: 781271 78121 (01)00884838068452(21)78121 78150 (01)00884838068452(21)78150 78157 (01)00884838068452(21)78157 78096 N/A 78208 (01)00884838068452(21)78208 78094 N/A 78012 N/A 78074 N/A 78154 (01)00884838068452(21)78154 78161 N/A 78172 (01)00884838068452(21)78172 78170 (01)00884838068452(21)78170 78182 (01)00884838068452(21)78182 78183 (01)00884838068452(21)78183 78205 (01)00884838068452(21)78205 78196 (01)00884838068452(21)78196 78171 (01)00884838068452(21)78171 78213 (01)00884838068452(21)78213 78221 (01)00884838068452(21)78221 78210 (01)00884838068452(21)78210 78212 (01)00884838068452(21)78212 78233 (01)00884838068452(21)78233 78190 (01)00884838068452(21)78190 78198 (01)00884838068452(21)78198 78216 (01)00884838068452(21)78216 78225 (01)00884838068452(21)78225 78238 N/A 78242 (01)00884838068452(21)78242 78173 (01)00884838068452(21)78173 78251 (01)00884838068452(21)78251 78250 (01)00884838068452(21)78250 78241 (01)00884838068452(21)78241 78235 (01)00884838068452(21)78235 78262 (01)00884838068452(21)78262 78253 (01)00884838068452(21)78253 78244 (01)00884838068452(21)78244 78252 (01)00884838068452(21)78252 78256 (01)00884838068452(21)78256 78263 (01)00884838068452(21)78263 78257 N/A 78266 (01)00884838068452(21)78266 78267 (01)00884838068452(21)78267 78269 (01)00884838068452(21)78269 78265 (01)00884838068452(21)78265 78270 (01)00884838068452(21)78270 78284 (01)00884838068452(21)78284 78281 (01)00884838068452(21)78281 78289 (01)00884838068452(21)78289 78293 (01)00884838068452(21)78293 78271 (01)00884838068452(21)78271 78218 (01)00884838068452(21)78218 78291 (01)00884838068452(21)78291 78283 (01)00884838068452(21)78283 78273 (01)00884838068452(21)78273 78305 (01)00884838068452(21)78305 78268 (01)00884838068452(21)78268 78282 (01)00884838068452(21)78282 78279 (01)00884838068452(21)78279 78292 (01)00884838068452(21)78292 78309 (01)00884838068452(21)78309 78288 (01)00884838068452(21)78288 78314 (01)00884838068452(21)78314 78306 (01)00884838068452(21)78306 78319 (01)00884838068452(21)78319 78320 (01)00884838068452(21)78320 78307 (01)00884838068452(21)78307 78296 (01)00884838068452(21)78296 78280 (01)00884838068452(21)78280 78313 (01)00884838068452(21)78313 78317 (01)00884838068452(21)78317 78321 (01)00884838068452(21)78321 78322 (01)00884838068452(21)78322 78316 (01)00884838068452(21)78316 78310 (01)00884838068452(21)78310 78308 (01)00884838068452(21)78308 78312 (01)00884838068452(21)78312 78240 (01)00884838068452(21)78240 78329 (01)00884838068452(21)78329 78272 (01)00884838068452(21)78272 78189 (01)00884838068452(21)78189 78330 (01)00884838068452(21)78330 78332 (01)00884838068452(21)78332 78334 (01)00884838068452(21)78334 78340 (01)00884838068452(21)78340 78243 (01)00884838068452(21)78243 78294 (01)00884838068452(21)78294 78335 (01)00884838068452(21)78335 78345 (01)00884838068452(21)78345 78295 (01)00884838068452(21)78295 78333 (01)00884838068452(21)78333 78342 (01)00884838068452(21)78342 78341 (01)00884838068452(21)78341 78327 (01)00884838068452(21)78327 78347 (01)00884838068452(21)78347 78224 (01)00884838068452(21)78224 78030 N/A 78036 N/A 78059 N/A 78156 (01)00884838068452(21)78156 78249 (01)00884838068452(21)78249 78080 (01)00884838068452(21)78080 78078 (01)00884838068452(21)78078 78098 (01)00884838068452(21)78098 78003 N/A 78017 N/A 78065 N/A 78070 N/A 78081 N/A 78076 N/A 78087 N/A 78101 (01)00884838068452(21)78101 78097 (01)00884838068452(21)78097 78104 (01)00884838068452(21)78104 78099 (01)00884838068452(21)78099 78107 (01)00884838068452(21)78107 78126 (01)00884838068452(21)78126 78149 (01)00884838068452(21)78149 78151 (01)00884838068452(21)78151 78181 N/A 78219 (01)00884838068452(21)78219 78206 (01)00884838068452(21)78206 78264 (01)00884838068452(21)78264 78063 N/A 78064 N/A 78106 (01)00884838068452(21)78106 78187 (01)00884838068452(21)78187 78000 N/A 78005 N/A 78007 N/A 78009 N/A 78016 N/A 78015 N/A 78018 N/A 78023 N/A 78019 N/A 78021 N/A 78027 N/A 78010 N/A 78029 N/A 78031 N/A 78025 N/A 78033 N/A 78032 N/A 78038 N/A 78035 N/A 78039 N/A 78040 N/A 78045 N/A 78043 N/A 78042 N/A 78049 N/A 78048 N/A 78050 N/A 78051 N/A 78062 N/A 78068 (01)00884838068452(21)78068 78067 N/A 78072 (01)00884838068452(21)78072 78084 N/A 78089 (01)00884838068452(21)78089 78082 N/A 78083 (01)00884838068452(21)78083 78091 (01)00884838068452(21)78091 78095 (01)00884838068452(21)78095 78088 (01)00884838068452(21)78088 78100 (01)00884838068452(21)78100 78111 N/A 78115 (01)00884838068452(21)78115 78117 (01)00884838068452(21)78117 78113 (01)00884838068452(21)78113 78114 (01)00884838068452(21)78114 78109 (01)00884838068452(21)78109 78132 (01)00884838068452(21)78132 78127 (01)00884838068452(21)78127 78133 (01)00884838068452(21)78133 78139 (01)00884838068452(21)78139 78140 (01)00884838068452(21)78140 78129 (01)00884838068452(21)78129 78147 (01)00884838068452(21)78147 78148 (01)00884838068452(21)78148 78145 (01)00884838068452(21)78145 78155 (01)00884838068452(21)78155 78203 (01)00884838068452(21)78203 78199 (01)00884838068452(21)78199 78207 (01)00884838068452(21)78207 78222 (01)00884838068452(21)78222 78223 (01)00884838068452(21)78223 78214 (01)00884838068452(21)78214 78011 N/A 78014 N/A 78013 N/A 78028 N/A 78034 N/A 78044 N/A 78047 N/A 78046 N/A 78073 N/A 78058 N/A 78071 (01)00884838068452(21)78071 78086 N/A 78075 N/A 78066 N/A 78060 (01)00884838068452(21)78060 78092 (01)00884838068452(21)78092 78102 (01)00884838068452(21)78102 78077 (01)00884838068452(21)78077 78110 (01)00884838068452(21)78110 78112 (01)00884838068452(21)78112 78103 (01)00884838068452(21)78103 78120 (01)00884838068452(21)78120 78122 (01)00884838068452(21)78122 78123 (01)00884838068452(21)78123 78128 (01)00884838068452(21)78128 78118 (01)00884838068452(21)78118 78135 (01)00884838068452(21)78135 78142 (01)00884838068452(21)78142 78141 (01)00884838068452(21)78141 78158 (01)00884838068452(21)78158 78162 (01)00884838068452(21)78162 78165 (01)00884838068452(21)78165 78167 (01)00884838068452(21)78167 78138 (01)00884838068452(21)78138 78164 (01)00884838068452(21)78164 78166 (01)00884838068452(21)78166 78175 (01)00884838068452(21)78175 78180 (01)00884838068452(21)78180 78186 (01)00884838068452(21)78186 78188 (01)00884838068452(21)78188 78137 (01)00884838068452(21)78137 78195 (01)00884838068452(21)78195 78197 (01)00884838068452(21)78197 78209 (01)00884838068452(21)78209 78193 (01)00884838068452(21)78193 78201 (01)00884838068452(21)78201 78215 (01)00884838068452(21)78215 78217 (01)00884838068452(21)78217 78202 (01)00884838068452(21)78202 78232 (01)00884838068452(21)78232 78194 (01)00884838068452(21)78194 78227 (01)00884838068452(21)78227 78234 (01)00884838068452(21)78234 78255 (01)00884838068452(21)78255 78254 (01)00884838068452(21)78254 78247 (01)00884838068452(21)78247 78259 (01)00884838068452(21)78259 78239 (01)00884838068452(21)78239 78260 (01)00884838068452(21)78260 78261 (01)00884838068452(21)78261 78287 (01)00884838068452(21)78287 78286 (01)00884838068452(21)78286 78299 (01)00884838068452(21)78299 78290 (01)00884838068452(21)78290 78298 (01)00884838068452(21)78298 78297 (01)00884838068452(21)78297 78229 (01)00884838068452(21)78229 78277 (01)00884838068452(21)78277 78326 (01)00884838068452(21)78326 78337 (01)00884838068452(21)78337 78324 (01)00884838068452(21)78324 78336 (01)00884838068452(21)78336 78004 N/A 78008 N/A 78053 N/A 78026 N/A 78022 N/A
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2420-2021
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