Recall of Device Recall Edwards Vigilance II Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences, Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45464
  • Event Risk Class
    Class 2
  • Event Number
    Z-0262-2008
  • Event Initiated Date
    2007-05-17
  • Event Date Posted
    2007-11-24
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2009-10-09
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Vigilance II Monitor - Product Code DXG
  • Reason
    Map offset errors: if users are "slaving" mean arterial pressure (map) from the bedside monitor into the vigilance ii monitor for the purpose of the continuous calculation of systemic vascular resistance (svr), at times, on some bedside monitors, the vigilance ii monitor may display a map offset of as much as 25mmhg. since the map is used in calculations of various patient parameters such as svr,.
  • Action
    An Urgent Customer notification letter dated May 17, 2007 was mailed to all Vigilance II customers advising that If they are "slaving" mean arterial pressure (MAP) from their bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), to be aware that at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25 mmHg. Since the MAP is used in calculations of various patient parameters such as SVR, these may also not be accurate. A table is provided showing those bedside monitors with the problem: GE Solar, Phillips (HP) M1006A, M1006B, as well as, those bedside monitors verified to not have the problem: SpaceLabs Model 90402 and Nihon Kohden Model BSM 8000. The letter also serves to remind the customer of the Warning in the Vigilance II Directions for Use which is also provided in the letter that instructs user to verify slaved MAP values with those displayed on bedside monitor. A temporary work around for this offset problem is to manually enter the MAP based on the readings from the bedside monitor. All Vigilance II calculations from the MAP have been re-verified to be correct when the MAP is accurate. The problem is in the transfer of the MAP between the bedside monitor and the Vigilance II. Customers are also advised that if they have the GE Solar or the Phillips (HP) models listed in the letter or any monitor not listed as verified to be compatible with the Vigilance II (Space labs and Nihon Kohden models listed above) Edwards recommends verification of MAP accuracy prior to treating based on parameters from a Vigilance II in a "slave" configuration. If there is a difference, they should enter the MAP into the Vigilance II manually for a static calculation of SVR. Edwards will be supplying a software update to correct this problem.

Device

  • Model / Serial
    VG000034  VG000049  VG000114 VG000124  VG000125  VG000128  VG000128  VG000129  VG000131  VG000132  VG000133  VG000134  VG000135  VG000136  VG000137  VG000138  VG000139  VG000140  VG000142  VG000143  VG000144  VG000145  VG000146  VG000148  VG000149  VG000150  VG000151  VG000152  VG000153  VG000155  VG000157  VG000163  VG000164  VG000169  VG000170  VG000171  VG000172  VG000173  VG000175  VG000176  VG000177  VG000178  VG000180  VG000181  VG000183  VG000185  VG000187  VG000188  VG000189  VG000191  VG000192  VG000195  VG000199  VG000200  VG000201  VG000203  VG000204  VG000206  VG000207  VG000209  VG000210  VG000211  VG000212  VG000213  VG000214  VG000215  VG000216  VG000220  VG000224  VG000225  VG000229  VG000230  VG000231  VG000232  VG000237  VG000238  VG000239  VG000250  VG000251  VG000254  VG000255  VG000256  VG000257  VG000259  VG000280  VG000289  VG000295  VG000296  VG000297  VG000299  VG000302  VG000304  VG000308  VG000320  VG000322  VG000323  VG000326  VG000333  VG000335  VG000336  VG000340  VG000343  VG000345  VG000346  VG000348  VG000351  VG000352  VG000353  VG000354  VG000355  VG000360  VG000364  VG000368  VG000369  VG000370  VG000371  VG000372  VG000381  VG000382  VG000384  VG000387  VG000391  VG000393  VG000394  VG000400  VG000402  VG000418  VG000419  VG000424  VG000425  VG000426  VG000427  VG000428  VG000429  VG000433  VG000436  VG000438  VG000440  VG000442  VG000449  VG000450  VG000453  VG000455  VG000457  VG000458  VG000461  VG000462  VG000463  VG000464  VG000466  VG000467  VG000470  VG000471  VG000473  VG000475  VG000476  VG000477  VG000478  VG000479  VG000480  VG000481  VG000482  VG000483  VG000484  VG000485  VG000486  VG000487  VG000488  VG000490  VG000491  VG000492  VG000492  VG000494  VG000495  VG000498  VG000499  VG000500  VG000501  VG000503  VG000504  VG000508  VG000509  VG000510  VG000514  VG000515  VG000517  VG000518  VG000519  VG000520  VG000521  VG000522  VG000523  VG000524  VG000526  VG000527  VG000528  VG000529 VG000530  VG000531  VG000531a  VG000532  VG000533  VG000534  VG000535  VG000535a  VG000536  VG000537  VG000538  VG000539  VG000540  VG000541  VG000542  VG000543  VG000544  VG000545  VG000546  VG000547  VG000548  VG000549  VG000550  VG000551  VG000552  VG000553  VG000554  VG000557  VG000558  VG000560  VG000561  VG000562  VG000563  VG000565  VG000566  VG000567  VG000568  VG000570  VG000571  VG000573  VG000575  VG000576  VG000577  VG000578  VG000579  VG000581  VG000582  VG000585  VG000586  VG000587  VG000588  VG000589  VG000590  VG000591  VG000592  VG000593  VG000594  VG000595  VG000596  VG000597  VG000599  VG000600  VG000601  VG000602  VG000603  VG000604  VG000606  VG000608  VG000609  VG000612  VG000613  VG000614  VG000616  VG000618  VG000619  VG000620  VG000621  VG000623  VG000626  VG000627  VG000629  VG000631  VG000633  VG000635  VG000636  VG000637  VG000639  VG000640  VG000641  VG000642  VG000643  VG000644  VG000647  VG000648  VG000649  VG000650  VG000652  VG000653  VG000654  VG000656  VG000659  VG000660  VG000661  VG000661  VG000662  VG000664  VG000665  VG000667  VG000668  VG000671  VG000673  VG000674  VG000675  VG000677  VG000678  VG000679  VG000679  VG000680  VG000681  VG000682  VG000684  VG000685  VG000687  VG000690  VG000691  VG000692  VG000694  VG000695  VG000697  VG000698  VG000700  VG000701  VG000702  VG000703  VG000704  VG000705  VG000706  VG000707  VG000708  VG000709  VG000710  VG000711  VG000712  VG000713  VG000714  VG000715  VG000717  VG000719  VG000722  VG000723  VG000724  VG000725  VG000728  VG000729  VG000731  VG000732  VG000733  VG000735  VG000736  VG000739  VG000740  VG000741  VG000742  VG000745  VG000746  VG000748  VG000749  VG000751  VG000753  VG000755  VG000757  VG000758  VG000759  VG000760  VG000761  VG000762  VG000763  VG000764  VG000765  VG000766  VG000768  VG000769  VG000770  VG000771  VG000772  VG000773  VG000774  VG000777  VG000778  VG000779  VG000780  VG000785  VG000786  VG000787  VG000789  VG000791  VG000792  VG000813  VG000857  VG000882  VG000883  VG000884  VG000885  VG000886  VG000887  VG000888  VG000889  VG000890  VG000891  VG000892  VG000894  VG000895  VG000896  VG000897  VG000898  VG000900  VG000901  VG000903  VG000904  VG000905  VG000906  VG000907  VG000908  VG000910  VG000911  VG000912  VG000914  VG000915  VG000918  VG000919  VG000920  VG000921  VG000922  VG000923  VG000925  VG000927  VG000928  VG000929  VG000930  VG000931  VG000932  VG000935  VG000936  VG000937  VG000938  VG000940  VG000941  VG000942  VG000947  VG000948  VG000951  VG000952  VG000953  VG000955  VG000957  VG000958  VG000961  VG000962  VG000963  VG000964  VG000965  VG000966  VG000967  VG000969  VG000970  VG000971  VG000972  VG000973  VG000974  VG000975  VG000976  VG000977  VG000978  VG000979  VG000980  VG000981  VG000982  VG000983  VG000984  VG000985  VG000986  VG000987  VG000988  VG000989  VG000990  VG000991  VG000992  VG000993  VG000994  VG000995  VG000997  VG000998  VG000999  VG001000  VG001001  VG001003  VG001004  VG001005  VG001007  VG001008  VG001012  VG001013  VG001014  VG001015  VG001017  VG001018  VG001019  VG001020  VG001021  VG001022  VG001023  VG001024  VG001025  VG001026  VG001027  VG001029  VG001031  VG001032  VG001034  VG001035  VG001038  VG001041  VG001042  VG001043  VG001044  VG001045  VG001048  VG001049  VG001050  VG001052  VG001053  VG001055  VG001056  VG001057  VG001059  VG001061  VG001063  VG001071  VG001072  VG001074  VG001076  VG001077  VG001078  VG001079  VG001080  VG001081  VG001082  VG001084  VG001087  VG001088  VG001089  VG001091  VG001092  VG001096  VG001097  VG001100  VG001101  VG001102  VG001104  VG001106  VG001108  VG001110  VG001112  VG001113  VG001116  VG001117  VG001118  VG001120  VG001122  VG001124  VG001125  VG001126  VG001127  VG001128  VG001129  VG001130  VG001131  VG001132  VG001134  VG001135  VG001136  VG001137  VG001138  VG001140  VG001141  VG001143  VG001144  VG001145  VG001146  VG001147  VG001148  VG001149  VG001150  VG001151  VG001152  VG001153  VG001154  VG001155  VG001156  VG001157  VG001158  VG001159  VG001160  VG001161  VG001162  VG001164  VG001165  VG001166  VG001167  VG001169  VG001170  VG001173  VG001174  VG001175  VG001176  VG001177  VG001179  VG001181  VG001185  VG001186  VG001188  VG001189  VG001190  VG001191  VG001192  VG001193  VG001194  VG001195  VG001197  VG001201  VG001202  VG001203 VG001204  VG001206  VG001208  VG001210  VG001211  VG001214  VG001215  VG001216  VG001217  VG001218  VG001220  VG001222  VG001223  VG001226  VG001227  VG001229  VG001230  VG001231  VG001234  VG001239  VG001241  VG001244  VG001245  VG001246  VG001247  VG001248  VG001249  VG001250  VG001251  VG001252  VG001253  VG001254  VG001255  VG001256  VG001257  VG001257  VG001258  VG001259  VG001260  VG001262  VG001263  VG001264  VG001265  VG001266  VG001267  VG001268  VG001269  VG001270  VG001272  VG001275  VG001277  VG001281  VG001282  VG001284  VG001287  VG001289  VG001291  VG001294  VG001309  VG001311  VG001313  VG001321  VG001322  VG001324  VG001325  VG001326  VG001327  VG001328  VG001329  VG001330  VG001332  VG001335  VG001337  VG001338  VG001339  VG001340  VG001341  VG001342  VG001344  VG001345  VG001346  VG001347  VG001348  VG001349  VG001350  VG001351  VG001358  VG001360  VG001362  VG001367  VG001368  VG001369  VG001370  VG001371  VG001373  VG001380  VG001391  VG001398  VG001399  VG001406  VG001407  VG001418  VG001423  VG001429  VG001452  VG001453  VG001454  VG001455  VG001456  VG001458  VG001460  VG001461  VG001462  VG001463  VG001464  VG001465  VG001467  VG001468  VG001469  VG001470  VG001471  VG001472  VG001473  VG001474  VG001475  VG001476  VG001477  VG001478  VG001479  VG001480  VG001481  VG001482  VG001483  VG001484  VG001485  VG001486  VG001487  VG001488  VG001489  VG001490  VG001491  VG001492  VG001493  VG001494  VG001495  VG001496  VG001497  VG001498  VG001499  VG001500  VG001501  VG001502  VG001503  VG001504  VG001505  VG001506  VG001507  VG001508  VG001509  VG001510  VG001511  VG001512  VG001513  VG001516  VG001521  VG001530  VG001540  VG001542  VG001543  VG001544  VG001545  VG001546  VG001547  VG001552  VG001555  VG001556  VG001558  VG001560  VG001561  VG001562  VG001565  VG001566  VG001567  VG001569  VG001571  VG001574  VG001576  VG001577  VG001578  VG001579  VG001583  VG001584  VG001587  VG001595  VG001595  VG001596  VG001598  VG001599  VG001599  VG001602  VG001605  VG001606  VG001607  VG001608  VG001609  VG001612  VG001612  VG001613  VG001614  VG001615  VG001616  VG001617  VG001618  VG001619  VG001622  VG001623  VG001624  VG001625  VG001627  VG001628  VG001629  VG001630  VG001631  VG001633  VG001634  VG001636  VG001637  VG001639  VG001640  VG001643  VG001644  VG001647  VG001650  VG001654  VG001657  VG001666  VG001667  VG001675  VG001679  VG001685  VG001690  VG001692  VG001694  VG001697  VG001699  VG001702  VG001703  VG001707  VG001708  VG001709  VG001711  VG001712  VG001714  VG001715  VG001716  VG001717  VG001719  VG001720  VG001721  VG001722  VG001724  VG001725  VG001727  VG001728  VG001729  VG001730  VG001731  VG001732  VG001736  VG001737  VG001738  VG001739  VG001740  VG001741  VG001742  VG001743  VG001744  VG001745  VG001746  VG001748  VG001749  VG001750  VG001751  VG001752  VG001753  VG001754  VG001755  VG001756  VG001758  VG001759  VG001761  VG001763  VG001764  VG001765  VG001766  VG001767  VG001768  VG001769  VG001771  VG001772  VG001773  VG001775  VG001776  VG001777  VG001779  VG001780  VG001782  VG001783  VG001784  VG001785  VG001786  VG001787  VG001788  VG001789  VG001790  VG001791  VG001792  VG001793  VG001794  VG001795  VG001796  VG001797  VG001798  VG001799  VG001800  VG001801  VG001802  VG001803  VG001804  VG001806  VG001807  VG001808  VG001809  VG001811  VG001812  VG001813  VG001814  VG001816  VG001818  VG001819  VG001820  VG001821  VG001822  VG001823  VG001824  VG001825  VG001826  VG001827  VG001828  VG001829  VG001830  VG001832  VG001833  VG001834  VG001835  VG001836  VG001838  VG001839  VG001840  VG001841  VG001842  VG001843  VG001844  VG001845  VG001846  VG001847 VG001849  VG001850  VG001851  VG001852  VG001853  VG001854  VG001855  VG001856  VG001857  VG001858  VG001859  VG001860  VG001861  VG001862  VG001863  VG001865  VG001866  VG001867  VG001868  VG001870  VG001871  VG001872  VG001874  VG001878  VG001879  VG001880  VG001881  VG001884  VG001887  VG001889  VG001890  VG001891  VG001892  VG001893  VG001894  VG001895  VG001896  VG001897  VG001898  VG001901  VG001902  VG001905  VG001906  VG001907  VG001909  VG001910  VG001911  VG001912  VG001913  VG001915  VG001916  VG001918  VG001919  VG001921  VG001926  VG001927  VG001934  VG001936  VG001938  VG001940  VG001942  VG001943  VG001945  VG001946  VG001947  VG001948  VG001949  VG001950  VG001951  VG001952  VG001953  VG001954  VG001956  VG001957  VG001958  VG001959  VG001960  VG001961  VG001962  VG001964  VG001965  VG001966  VG001968  VG001969  VG001970  VG001971  VG001973  VG001974  VG001975  VG001976  VG001977  VG001978  VG001979  VG001980  VG001982  VG001983  VG001984  VG001985  VG001987  VG001988  VG001989  VG001990  VG001991  VG001992  VG001993  VG001994  VG001995  VG001996  VG001997  VG001999  VG002000  VG002001  VG002003  VG002004  VG002005  VG002006  VG002007  VG002009  VG002010  VG002011 VG002012  VG002015  VG002016  VG002017  VG002018  VG002019  VG002021  VG002022  VG002024  VG002028  VG002029  VG002030  VG002031  VG002033  VG002035  VG002038  VG002041  VG002050  VG002057  VG002065  VG002067  VG002068  VG002071  VG002072  VG002078  VG002083  VG002085  VG002089  VG002092  VG002095  VG002099  VG002100  VG002102  VG002105  VG002108  VG002109  VG002112  VG002113  VG002115  VG002118  VG002119  VG002120  VG002129  VG002130  VG002131  VG002132  VG002133  VG002134  VG002135  VG002136  VG002139  VG002140  VG002142  VG002143  VG002145  VG002146  VG002147  VG002149  VG002151  VG002152  VG002153  VG002155  VG002156  VG002157  VG002158  VG002159  VG002160  VG002161  VG002162  VG002163  VG002164  VG002172  VG002189  VG002191  VG002192  VG002193  VG002194  VG002195  VG002196  VG002197  VG002198  VG002199  VG002200 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 VG003029  VG003030  VG003031  VG003032  VG003033  VG003034  VG003035  VG003037  VG003040  VG003042  VG003043  VG003047  VG003049  VG003052  VG003053  VG003055  VG003056  VG003057  VG003058  VG003060  VG003062  VG003064  VG003072  VG003073  VG003082  VG003084  VG003087  VG003088  VG003089  VG003090  VG003091  VG003092  VG003093  VG003094  VG003095  VG003096  VG003097  VG003099  VG003100  VG003101  VG003102  VG003103  VG003104  VG003106  VG003107  VG003108  VG003109  VG003110  VG003111  VG003112  VG003113  VG003114  VG003115  VG003116  VG003117  VG003118  VG003119  VG003120  VG003121  VG003122  VG003123  VG003125  VG003126  VG003127  VG003128  VG003129  VG003130  VG003132  VG003133  VG003134  VG003135  VG003137  VG003139  VG003141  VG003143  VG003148  VG003149  VG003150  VG003152  VG003154  VG003155  VG003156  VG003157  VG003158  VG003159  VG003161  VG003163  VG003164  VG003165  VG003167  VG003171  VG003173  VG003174  VG003178  VG003183  VG003184  VG003185  VG003187  VG003188  VG003190  VG003192  VG003193  VG003194  VG003195  VG003197  VG003199  VG003200  VG003201  VG003203  VG003204  VG003206  VG003207  VG003208  VG003210  VG003211  VG003213  VG003215  VG003216  VG003217  VG003218  VG003219  VG003220  VG003221  VG003222  VG003223  VG003225  VG003227  VG003228  VG003230  VG003231  VG003232  VG003234  VG003235  VG003238  VG003239  VG003240  VG003241  VG003254  VG003263  VG003266  VG003270  VG003271  VG003273  VG003275  VG003281  VG003282  VG003283 VG003285  VG003287  VG003289  VG003291  VG003294  VG003297  VG003300  VG003302  VG003307  VG003309  VG003313  VG003314  VG003319  VG003322  VG003323  VG003324  VG003325  VG003326  VG003327  VG003330  VG003331  VG003332  VG003333  VG003334  VG003335  VG003336  VG003337  VG003338  VG003339  VG003340  VG003341  VG003342  VG003343  VG003346  VG003347  VG003348  VG003351  VG003353  VG003355  VG003356  VG003357  VG003358  VG003360  VG003361  VG003363  VG003364  VG003366  VG003367  VG003369  VG003373  VG003374  VG003375  VG003377  VG003378  VG003380  VG003382  VG003382  VG003385  VG003386  VG003387  VG003388  VG003390  VG003391  VG003392  VG003394  VG003398  VG003399  VG003400  VG003401  VG003402  VG003403  VG003404  VG003405  VG003406  VG003407  VG003409  VG003410  VG003412  VG003413  VG003414  VG003415  VG003416  VG003417  VG003418  VG003419  VG003421  VG003422  VG003423  VG003424  VG003426  VG003428  VG003429  VG003429  VG003431  VG003432  VG003433  VG003435  VG003436  VG003437  VG003439  VG003440  VG003441  VG003442  VG003443  VG003444  VG003445  VG003446  VG003447  VG003448  VG003449  VG003450  VG003451  VG003452  VG003453  VG003454  VG003455  VG003456  VG003458  VG003459  VG003460  VG003461  VG003463  VG003464  VG003465  VG003466  VG003467  VG003468  VG003469  VG003470  VG003471  VG003472  VG003473  VG003474  VG003475  VG003476  VG003478  VG003479  VG003480  VG003481  VG003482  VG003484  VG003485  VG003486  VG003487  VG003488  VG003489  VG003490  VG003491  VG003492  VG003493  VG003495  VG003496  VG003497 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA and Canada
  • Product Description
    Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifesciences LLC., Irvine, CA 92614
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA