Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-01391...
FDA Device Recall #Z-0116-2020 — Class II — July 19, 2019
Recall Summary
| Recall Number | Z-0116-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 19, 2019 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 19351 devices |
Product Description
Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11. 1009-9000-000-004993 12. 1009-9011-000-004795 13. 1009-9000-000-013407 14. 1009-9000-000-004604 15. 1009-9000-000-017674 16. 1009-9000-000-008763 17. 1009-9000-000-008306 18. 1009-9000-000-003277 19. 1009-9000-000-004166 20. 1009-9000-000-008560 21. 1009-9000-000-000299 22. 1009-9000-000-011444 23. 1009-9000-000-003529 24. 1009-9000-000-005666 25. 1009-9000-000-019821 26. 1009-9011-000 27. 1009-9000-000-017345 28. 1009-9000-000-009893 29. 1009-9000-000-007258 30. 1009-9000-000-004959 31. 1009-9000-000-010185 32. 1009-9000-000-016672 33. 1009-9011-000-017769 34. 1009-9000-000-014329 35. 1009-9011-000-020685 36. 1009-9000-000-026022 37. 1009-9011-000-002912 38. 1009-9000-000-014723 39. 1009-9000-000-013385 40. 1009-9000-000-006725 41. 1009-9000-000-005163 42. 1009-9000-000-004022 43. 1009-9000-000-017939 44. 1009-9000-000-000300 45. 1009-9000-000-018855 46. 1009-9000-000-016724 47. 1009-9000-000-010268 48. 1009-9000-000-011595 49. 1009-9000-000-019277 50. 1009-9011-000-023222 51. 1009-9011-000-015929 52. 1009-9000-000-017824 53. 1009-9000-000-008270 54. 1009-9000-000-010416 55. 1009-9000-000-019089 56. 1009-9000-000-013395 57. 1009-9011-000-021989 58. 1009-9000-000-000517 59. 1009-9000-000-002407 60. 1009-9000-000-008415 61. 1009-9000-000-009597 62. 1009-9000-000-010178 63. 1009-9011-000-010400 64. 1009-9011-000-011366 65. 1009-9000-000-012360 66. 1009-9101-000 67. 1009-9000-000-013787 68. 1009-9000-000-006266 69. 1009-9000-000-014915 70. 1009-9000-000-000290 71. 1009-9000-000-013507 72. 1009-9000-000-011600 73. 1009-9000-000-010595 74. 1009-9000-000-009543 75. 1009-9000-000-011111 76. 1009-9000-000-013378 77. 1009-9000-000-000526 78. 1009-9000-000-010536 79. 1009-9000-000-010116 80. 1009-9000-000-005939 81. 1009-9000-000-008216 82. 1009-9000-000-006786 83. 1009-9000-000-012155 84. 1009-9000-000-012379 85. 1009-9000-000-014000 86. 1009-9011-000-022466 87. 1009-9000-000-009912 88. 1009-9000-000-006906 89. 1009-9000-000-004380 90. 1009-9000-000-010245 91. 1009-9000-000-010413 92. 1009-9000-000-013616 93. 1009-9000-000-009428 94. 1009-9000-000-010597 95. 1009-9000-000-020606 96. 1009-9000-000-010059 97. 1009-9000-000-014122 98. 1009-9000-000-016795 99. 1009-9000-000-012149 100. 1009-9000-000-005760 101. 1009-9000-000-009836 102. 1009-9000-000-016818 103. 1009-9000-000-017699 104. 1009-9000-000-004020 105. 1009-9000-000-013953 106. 1009-9000-000-009583 107. 1009-9000-000-007938 108. 1009-9000-000-007336 109. 1009-9000-000-010435 110. 1009-9011-000-016719 111. 1009-9000-000-024098 112. 1009-9011-000-004634 113. 1009-9011-000-016794 114. 1009-9011-000-005431 115. 1009-9000-000-000598 116. 1009-9011-000-005442 117. 1009-9000-000-022792 118. 1009-9000-000-003950 119. 1009-9000-000-013921 120. 1009-9000-000-011116 121. 1009-9000-000-017203 122. 1009-9000-000-003335 123. 1009-9000-000-008264 124. 1009-9000-000-009868 125. 1009-9011-000-015245 truncated text
Reason for Recall
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.
Distribution Pattern
Worldwide
Lot / Code Information
Model, Catalogue or Code # Mfg. Lot or Serial # 1006-9012-000 AMVE00253 1006-9012-000 AMVF00911 1006-9012-000 AMVE00255 1006-9012-000 AMVF00605 1006-9012-000 AMVF00718 1006-9012-000 AMVF00920 1006-9012-000 AMVG00384 1006-9012-000 AMVE00252 1006-9012-000 AMVE00297 1006-9012-000 AMVF00373 1006-9012-000 AMVF00604 1006-9012-000 AMVF00677 1006-9012-000 AMVF00796 1006-9012-000 AMVF00797 1006-9012-000 AMVF01008 1006-9012-000 AMVE00298 1006-9012-000 AMVE00358 1006-9012-000 AMVE00322 1006-9012-000 AMVE00258 1006-9012-000 AMVE00259 1006-9012-000 AMVE00280 1006-9012-000 AMVE00281 1006-9012-000 AMVE00299 1006-9012-000 AMVH00464 1006-9012-000 AMVE00254 1006-9012-000 AMVE00256 1006-9012-000 AMVE00257 1006-9012-000 AMVE00324 1006-9012-000 AMVE00325 1006-9012-000 AMVG00363 1006-9012-000 AMVE00300 1006-9012-000 AMVF00361 1006-9012-000 AMVF00798 1006-9012-000 AMVF00921 1006-9012-000 AMVG00627 1006-9021-000 AMVH00192 1006-9021-000 AMVD00112 1006-9021-000 AMVD00113 1006-9021-000 AMVD00114 1006-9021-000 AMVE00135 1006-9021-000 AMVE00150 1006-9021-000 AMVG00385 1006-9021-000 AMVF00914 1006-9021-000 AMVG00386 1006-9021-000 AMVE00152 1006-9021-000 AMVF00457 1006-9021-000 AMVD00117 1006-9021-000 AMVG00466 1006-9021-000 AMVH00150 1006-9021-000 AMVH00199 1006-9021-000 AMVH00194 1006-9021-000 AMVD00111 1006-9021-000 AMVE00151 1006-9021-000 AMVH00193 1006-9021-000 AMVD00128 1006-9021-000 AMVF00676 1006-9021-000 AMVE00204 1006-9021-000 AMVE00323 1006-9021-000 AMVG00559 1006-9021-000 AMVH00149 1006-9021-000 AMVD00126 1006-9021-000 AMVH00191 1006-9024-000 AMVD00115 1006-9024-000 AMVE00220 1006-9026-000 AMVE00551 1006-9026-000 AMVF00992 1006-9026-000 AMVF01276 1006-9031-000 AMVE00203 1006-9031-000 AMVE00321 1006-9111-000 AMVF01237 1006-9111-000 AMVF01264 1006-9111-000 AMVF01265 1006-9111-000 AMVG00232 1006-9111-000 AMVF01189 1006-9111-000 AMVF01487 1006-9111-000 AMVG00626 1006-9111-000 AMVG00153 1006-9111-000 AMVF01578 1006-9111-000 AMVF01579 1006-9111-000 AMVG00233 1006-9111-000 AMVG00234 1006-9111-000 AMVF01582 1006-9111-000 AMVG00249 1006-9111-000 AMVG00250 1006-9111-000 AMVG00251 1006-9111-000 AMVG00252 1006-9111-000 AMVG00253 1006-9111-000 AMVF01166 1006-9111-000 AMVF01191 1006-9111-000 AMVG00967 1006-9111-000 AMVG00968 1006-9111-000 AMVG00821 1006-9111-000 AMVE01000 1006-9111-000 AMVG00778 1006-9111-000 AMVG00623 1006-9111-000 AMVG00969 1006-9111-000 AMVG01049 1006-9111-000 AMVG00151 1006-9111-000 AMVF00909 1006-9111-000 AMVF00910 1006-9111-000 AMVF01465 1006-9111-000 AMVF01186 1006-9111-000 AMVE00618 1006-9111-000 AMVE00619 1006-9111-000 AMVE00620 1006-9111-000 AMVE00621 1006-9111-000 AMVF01187 1006-9111-000 AMVF01188 1006-9111-000 AMVE00919 1006-9111-000 AMVE00920 1006-9111-000 AMVG00966 1006-9111-000 AMVF01167 1006-9111-000 AMVF01390 1006-9111-000 AMVG00736 1006-9111-000 AMVG00624 1006-9111-000 AMVF00599 1006-9111-000 AMVG00891 1006-9111-000 AMVF01580 1006-9111-000 AMVF00827 1006-9111-000 AMVF00828 1006-9111-000 AMVF00602 1006-9111-000 AMVF00824 1006-9111-000 AMVF01393 1006-9111-000 AMVF00148 1006-9111-000 AMVG00235 1006-9111-000 AMVG00781 1006-9111-000 AMVG00260 1006-9111-000 AMVG00261 1006-9111-000 AMVG00262 1006-9111-000 AMVG00620 1006-9111-000 AMVG00621 1006-9111-000 AMVG00258 1006-9111-000 AMVF00825 1006-9111-000 AMVF00826 1006-9111-000 AMVF01581 1006-9111-000 AMVF00906 1006-9111-000 AMVF00907 1006-9111-000 AMVF00597 1006-9111-000 AMVF00918 1006-9111-000 AMVF00919 1006-9111-000 AMVF01052 1006-9111-000 AMVF01053 1006-9111-000 AMVF01054 1006-9111-000 AMVF01055 1006-9111-000 AMVF01056 1006-9111-000 AMVF01057 1006-9111-000 AMVF01058 1006-9111-000 AMVG00779 1006-9111-000 AMVG00780 1006-9111-000 AMVG00818 1006-9111-000 AMVG00819 1006-9111-000 AMVG00820 1006-9111-000 AMVF00915 1006-9111-000 AMVF01658 1006-9111-000 AMVF01659 1006-9111-000 AMVF01323 1006-9111-000 AMVF01324 1006-9111-000 AMVG00256 1006-9111-000 AMVG00257 1006-9111-000 AMVF00145 1006-9111-000 AMVG00150 1006-9111-000 AMVG00152 1006-9111-000 AMVF00147 1006-9111-000 AMVF00600 1006-9111-000 AMVG01050 1006-9111-000 AMVF00912 1006-9111-000 AMVF01657 1006-9111-000 AMVE00983 1006-9111-000 AMVE00984 1006-9111-000 AMVF01190 1006-9111-000 AMVG00777 1006-9111-000 AMVG00907 1006-9111-000 AMVG00908 1006-9111-000 AMVG00909 1006-9111-000 AMVF01462 1006-9111-000 AMVG00110 1006-9111-000 AMVG00149 1006-9111-000 AMVG00248 1006-9111-000 AMVG00960 1006-9111-000 AMVF00598 1006-9111-000 AMVF01463 1006-9111-000 AMVG00259 1006-9111-000 AMVF00149 1006-9111-000 AMVF00593 1006-9111-000 AMVG00387 1006-9111-000 AMVG00388 1006-9111-000 AMVG00389 1006-9111-000 AMVF01115 1006-9111-000 AMVE00967 1006-9111-000 AMVG00625 1006-9111-000 AMVF00596 1006-9111-000 AMVF00595 1006-9111-000 AMVE00977 1006-9111-000 AMVG00228 1006-9111-000 AMVG00229 1006-9111-000 AMVG00230 1006-9111-000 AMVG00231 1006-9111-000 AMVG00226 1006-9111-000 AMVG00227 1006-9111-000 AMVG00622 1006-9111-000 AMVF00146 1006-9111-000 AMVE01002 1006-9111-000 AMVF00594 1006-9111-000 AMVF00601 1006-9111-000 AMVF00917 1006-9111-000 AMVF00908 1006-9111-000 AMVF01059 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AMVE00445 1006-9320-000 AMVE00372 1006-9320-000 AMVE00732 1006-9320-000 AMVE00733 1006-9320-000 AMVE00734 1006-9320-000 AMVE00767 1006-9320-000 AMVE00879 1006-9320-000 AMVE00881 1006-9320-000 AMVE00882 1006-9320-000 AMVF01353 1006-9320-000 AMVF01051 1006-9320-000 AMVH00821 1006-9320-000 AMVE00433 1006-9320-000 AMVE00891 1006-9320-000 AMVE00899 1006-9320-000 AMVF00276 1006-9320-000 AMVF00786 1006-9320-000 AMVF01572 1006-9320-000 AMVF01573 1006-9320-000 AMVF01575 1006-9320-000 AMVF01576 1006-9320-000 AMVF01577 1006-9320-000 AMVF01643 1006-9320-000 AMVF01644 1006-9320-000 AMVF01645 1006-9320-000 AMVG00812 1006-9320-000 AMVH00533 1006-9320-000 AMVH00837 1006-9320-000 AMVH00838 1006-9320-000 AMVH00839 1006-9320-000 AMVH00840 1006-9320-000 AMVH00841 1006-9320-000 AMVH00842 1006-9320-000 AMVH00843 1006-9320-000 AMVF01049 1006-9320-000 AMVJ00212 1006-9320-000 AMVE00465 1006-9320-000 AMVE00466 1006-9320-000 AMVE00467 1006-9320-000 AMVE00468 1006-9320-000 AMVE00482 1006-9320-000 AMVE00729 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1006-9320-000 AMVE00406 1006-9320-000 AMVH00333 1006-9320-000 AMVH00579 1006-9320-000 AMVG00715 1006-9320-000 AMVF01427 1006-9320-000 AMVF01355 1006-9320-000 AMVF01356 1006-9320-000 AMVF01358 1006-9320-000 AMVG01057 1006-9320-000 AMVG01058 1006-9320-000 AMVG01059 1006-9320-000 AMVG01060 1006-9320-000 AMVG00342 1006-9320-000 AMVG00343 1006-9320-000 AMVG00344 1006-9320-000 AMVG00345 1006-9320-000 AMVG00346 1006-9320-000 AMVF01429 1006-9320-000 AMVF01430 1006-9320-000 AMVF01431 1006-9320-000 AMVE00222 1006-9320-000 AMVJ00128 1006-9320-000 AMVF00734 1006-9320-000 AMVF00787 1006-9320-000 AMVF00788 1006-9320-000 AMVF01364 1006-9320-000 AMVF01416 1006-9320-000 AMVF01417 1006-9320-000 AMVF01418 1006-9320-000 AMVF01470 1006-9320-000 AMVG00139 1006-9320-000 AMVG00853 1006-9320-000 AMVG00854 1006-9320-000 AMVG00855 1006-9320-000 AMVE00319 1006-9320-000 AMVE00320 1006-9320-000 AMVF00712 1006-9320-000 AMVF00713 1006-9320-000 AMVF00714 1006-9320-000 AMVF00715 1006-9320-000 AMVF00716 1006-9320-000 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AMVJ00199 1006-9320-000 AMVJ00200 1006-9320-000 AMVJ00201 1006-9320-000 AMVH00906 1006-9320-000 AMVH00907 1006-9320-000 AMVE00715 1006-9320-000 AMVE00716 1006-9320-000 AMVH00901 1006-9320-000 AMVJ00120 1006-9320-000 AMVJ00176 1006-9320-000 AMVJ00177 1006-9320-000 AMVF01303 1006-9320-000 AMVH00781 1006-9320-000 AMVE00579 1006-9320-000 AMVE00580 1006-9320-000 AMVG00303 1006-9320-000 AMVG00304 1006-9320-000 AMVH00644 1006-9320-000 AMVH00645 1006-9320-000 AMVH00672 1006-9320-000 AMVH00673 1006-9320-000 AMVH00674 1006-9320-000 AMVH00675 1006-9320-000 AMVH00690 1006-9320-000 AMVH00691 1006-9320-000 AMVH00805 1006-9320-000 AMVE00581 1006-9320-000 AMVE00589 1006-9320-000 AMVF00244 1006-9320-000 AMVF00245 1006-9320-000 AMVF00246 1006-9320-000 AMVF00405 1006-9320-000 AMVH00138 1006-9320-000 AMVE00475 1006-9320-000 AMVE00731 1006-9320-000 AMVF01297 1006-9320-000 AMVG00636 1006-9320-000 AMVD00122 1006-9320-000 AMVD00123 1006-9320-000 AMVD00124 1006-9320-000 AMVD00140 1006-9320-000 AMVE00175 1006-9320-000 AMVE00177 1006-9320-000 AMVE00179 1006-9320-000 AMVE00450 1006-9320-000 AMVE00457 1006-9320-000 AMVE00955 1006-9320-000 AMVG00157 1006-9320-000 AMVG00568 1006-9320-000 AMVG00569 1006-9320-000 AMVG01037 1006-9320-000 AMVG01061 1006-9320-000 AMVH00666 1006-9320-000 AMVD00168 1006-9320-000 AMVD00178 1006-9320-000 AMVD00104 1006-9320-000 AMVE00153 1006-9320-000 AMVE00154 1006-9320-000 AMVE00176 1006-9320-000 AMVE00178 1006-9320-000 AMVE00380 1006-9320-000 AMVE00381 1006-9320-000 AMVE00382 1006-9320-000 AMVE00458 1006-9320-000 AMVE00459 1006-9320-000 AMVE00460 1006-9320-000 AMVE00777 1006-9320-000 AMVE00778 1006-9320-000 AMVE00779 1006-9320-000 AMVE00780 1006-9320-000 AMVE00781 1006-9320-000 AMVE00782 1006-9320-000 AMVE00886 1006-9320-000 AMVE00887 1006-9320-000 AMVE00889 1006-9320-000 AMVE00963 1006-9320-000 AMVE00964 1006-9320-000 AMVF00136 1006-9320-000 AMVF00243 1006-9320-000 AMVF00278 1006-9320-000 AMVF00279 1006-9320-000 AMVF00280 1006-9320-000 AMVF00281 1006-9320-000 AMVF00461 1006-9320-000 AMVF00462 1006-9320-000 AMVF00463 1006-9320-000 AMVF00464 1006-9320-000 AMVF00465 1006-9320-000 AMVF00466 1006-9320-000 AMVF00470 1006-9320-000 AMVF00793 1006-9320-000 AMVF00794 1006-9320-000 AMVF01157 1006-9320-000 AMVF01158 1006-9320-000 AMVF01159 1006-9320-000 AMVF01279 1006-9320-000 AMVF01280 1006-9320-000 AMVF01281 1006-9320-000 AMVF01282 1006-9320-000 AMVF01284 1006-9320-000 AMVF01285 1006-9320-000 AMVF01302 1006-9320-000 AMVF01359 1006-9320-000 AMVF01544 1006-9320-000 AMVF01545 1006-9320-000 AMVF01546 1006-9320-000 AMVF01574 1006-9320-000 AMVF01655 1006-9320-000 AMVG00101 1006-9320-000 AMVG00711 1006-9320-000 AMVG00874 1006-9320-000 AMVG00875 1006-9320-000 AMVG00980 1006-9320-000 AMVG00981 1006-9320-000 AMVH00367 1006-9320-000 AMVH00368 1006-9320-000 AMVH00369 1006-9320-000 AMVE00670 1006-9320-000 AMVF00123 1006-9320-000 AMVF00124 1006-9320-000 AMVF00126 1006-9320-000 AMVF00127 1006-9320-000 AMVF00530 1006-9320-000 AMVF00531 1006-9320-000 AMVF00532 1006-9320-000 AMVF00533 1006-9320-000 AMVF00534 1006-9320-000 AMVF00535 1006-9320-000 AMVF00536 1006-9320-000 AMVF01348 1006-9320-000 AMVF01349 1006-9320-000 AMVF01350 1006-9320-000 AMVF01351 1006-9320-000 AMVF01352 1006-9320-000 AMVG00492 1006-9320-000 AMVG00493 1006-9320-000 AMVG00494 1006-9320-000 AMVG00495 1006-9320-000 AMVG00496 1006-9320-000 AMVG00497 1006-9320-000 AMVG00498 1
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.