Aespire 7100
Medical device recall Z-0116-2020. Published in FDA’s Enforcement Report on Dec 25, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 25, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 19351 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
19351 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,992 characters
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…
FDA’s list runs to 557,831 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 19, 2019.
- FDA classified it on Dec 17, 2019.
- FDA’s Enforcement Report published it on Dec 25, 2019.
- FDA terminated it on Apr 13, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 557,831 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.