Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Class I - DangerousWhat Should You Do?
- Check if you have this product: (Added 6/25/18): 32550 22129 20226 21715 21558 21805 22134 13005 20027 21789 21264 21236 12078 20129 21639 20021 33037 21230 21231 20249 32171 21493 20149 8770 20154 32816 20173 20260 22096 21999 20050 20213 12074 21968 32508 21482 21688 39035 39005 21935 21572 20071 12100 12124 21891 39068 21609 22315 20106 39060 21998 32080 18673 21045 20331 22207 32500 32219 21099 8715 21351 21334 11024 8442 32085 8971 32084 22319 22286 21666 21693 32481 8165 21066 32003 8996 11027 33625 21930 21321 21798 20185 21776 22012 22167 12017 32344 21036 20321 20000 22089 21237 20282 32034 22245 11028 32131 39024 20257 21192 21957 21634 32616 21464 32346 20156 20065 21752 11052 21284 22001 11019 33675 10077 11094 21878 21328 21320 20236 20252 21070 20281 21479 20096 20126 21879 21976 21380 12061 21599 20204 20028 21681 11069 12021 12012 20161 32644 21304 13081 20141 32388 21268 21773 12056 12181 20248 32390 22212 21860 32689 39021 32739 11081 11059 32792 21721 20120 32083 21851 11007 21574 32002 20072 21638 11048 21687 20291 32329 39055 22140 21788 21108 21962 39025 21251 22066 21883 21806 11058 8371 12065 21965 20210 21076 12182 32233 18528 32474 21494 32824 21882 21176 22008 20062 32314 22130 32174 32033 21973 22210 8361 21113 22288 32966 11080 20023 20036 22155 21111 21168 20045 20047 11015 32185 21664 32424 20119 20280 22159 33157 22215 21925 12015 21993 12132 12112 21183 32463 32717 11074 32198 21110 11037 22222 20049 32772 32712 22004 39027 12106 13012 20088 21508 21868 22110 21103 21340 21381 8578 12031 32095 20118 21106 21967 21754 20005 21712 20314 22084 21603 12123 22252 22268 39061 32226 32507 32343 20212 22092 32581 21313 22160 21504 21713 32351 11020 12051 39016 12034 21377 13020 21589 21435 21953 8020 11090 21424 10058 21096 20272 32255 11026 20277 20297 21290 12064 20128 21958 22136 20058 21725 12066 32381 13066 21104 20307 21071 21405 11016 20265 13048 13049 11010 21286 22025 21178 20179 21240 12037 21630 12144 21667 32125 32517 39017 12024 10703 11023 21455 22343 8782 21272 21475 12075
- 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 Electronics North America Corporation
- Reason for Recall:
- Potential risk for helium gas inside the MR examination room during a magnet quench
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Product Codes/Lot Numbers:
(Added 6/25/18): 32550 22129 20226 21715 21558 21805 22134 13005 20027 21789 21264 21236 12078 20129 21639 20021 33037 21230 21231 20249 32171 21493 20149 8770 20154 32816 20173 20260 22096 21999 20050 20213 12074 21968 32508 21482 21688 39035 39005 21935 21572 20071 12100 12124 21891 39068 21609 22315 20106 39060 21998 32080 18673 21045 20331 22207 32500 32219 21099 8715 21351 21334 11024 8442 32085 8971 32084 22319 22286 21666 21693 32481 8165 21066 32003 8996 11027 33625 21930 21321 21798 20185 21776 22012 22167 12017 32344 21036 20321 20000 22089 21237 20282 32034 22245 11028 32131 39024 20257 21192 21957 21634 32616 21464 32346 20156 20065 21752 11052 21284 22001 11019 33675 10077 11094 21878 21328 21320 20236 20252 21070 20281 21479 20096 20126 21879 21976 21380 12061 21599 20204 20028 21681 11069 12021 12012 20161 32644 21304 13081 20141 32388 21268 21773 12056 12181 20248 32390 22212 21860 32689 39021 32739 11081 11059 32792 21721 20120 32083 21851 11007 21574 32002 20072 21638 11048 21687 20291 32329 39055 22140 21788 21108 21962 39025 21251 22066 21883 21806 11058 8371 12065 21965 20210 21076 12182 32233 18528 32474 21494 32824 21882 21176 22008 20062 32314 22130 32174 32033 21973 22210 8361 21113 22288 32966 11080 20023 20036 22155 21111 21168 20045 20047 11015 32185 21664 32424 20119 20280 22159 33157 22215 21925 12015 21993 12132 12112 21183 32463 32717 11074 32198 21110 11037 22222 20049 32772 32712 22004 39027 12106 13012 20088 21508 21868 22110 21103 21340 21381 8578 12031 32095 20118 21106 21967 21754 20005 21712 20314 22084 21603 12123 22252 22268 39061 32226 32507 32343 20212 22092 32581 21313 22160 21504 21713 32351 11020 12051 39016 12034 21377 13020 21589 21435 21953 8020 11090 21424 10058 21096 20272 32255 11026 20277 20297 21290 12064 20128 21958 22136 20058 21725 12066 32381 13066 21104 20307 21071 21405 11016 20265 13048 13049 11010 21286 22025 21178 20179 21240 12037 21630 12144 21667 32125 32517 39017 12024 10703 11023 21455 22343 8782 21272 21475 12075
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1435-2018
Related Recalls
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
Philips Electronics North America
There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.
A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet.
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.