Hearth Record

Aestiva 7100

Medical device recall Z-0117-2020. Published in FDA’s Enforcement Report on Dec 25, 2019.

FDA’s own record, on accessdata.fda.gov

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.

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.

Source:

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-015180 10. 1006-9320-000-010369 11. 1006-9321-000-019486 12. 1006-9321-000-007601 13. 1006-9321-000-009266 14. 1006-9321-000-008526 15. 1006-9321-000-116507 16. 1006-9321-000-009244 17. 1006-9321-000-012769 18. 1006-9320-000-004497 19. 1006-9320-000-009697 20. 1006-9320-000-014484 21. 1006-9321-000-008072 22. 1006-9321-000-007618 23. 1006-9321-000-013784 24. 1006-9320-000-010963 25. 1006-9320-000-014485 26. 1006-9320-000-008839 27. 1006-9321-000-017374 28. 1006-9321-000-014553 29. 1006-9031-000 30. 1006-9321-000-000533 31. 1006-9321-000-007785 32. 1006-9320-000-016418 33. 1006-9320-000-013302 34. 1006-9320-000-020339 35. 1006-9320-000-002141 36. 1006-9320-000-009193 37. 1006-9320-000-014443 38. 1006-9320-000-008124 39. 1006-9321-000-009347 40. 1006-9320-000-009310 41. 1006-9320-000-004623 42. 1006-9321-000-020437 43. 1006-9321-000-025830 44. 1006-9321-000-004690 45. 1006-9321-000-011348 46. 1006-9114-000 47. 1006-9322-000 48. 1006-9321-000-006678 49. 1006-9321-000-043401 50. 1006-9322-000-043399 51. 1006-9320-000-018778 52. 1006-9320-000-010161 53. 1006-9320-000-009400 54. 1006-9320-000-007948 55. 1006-9321-000-001309 56. 1006-9321-000-008305 57. 1006-9321-000-027472 58. 1006-9321-000-008643 59. 1006-9320-000-008841 60. 1006-9320-000-010102 61. 1006-9322-000-020407 62. 1006-9321-000-004831 63. 1006-9320-000-010684 64. 1006-9320-000-014654 65. 1006-9320-000-006392 66. 1006-9320-000-009056 67. 1006-9321-000-025850 68. 1006-9320-000-000473 69. 1006-9320-000-017639 70. 1006-9321-000-003110 71. 1006-9321-000-019653 72. 1006-9321-000-008529 73. 1006-9321-000-010029 74. 1006-9321-000-005790 75. 1006-9320-000-010177 76. 1006-9320-000-028131 77. 1006-9321-000-006318 78. 1006-9322-000-106884 79. 1006-9320-000-004596 80. 1006-9321-000-006645 81. 1006-9321-000-010584 82. 1006-9320-000-007779 83. 1006-9320-000-025679 84. 1006-9320-000-011509 85. 1006-9320-000-008650 86. 1006-9321-000-020045 87. 1006-9321-000-014996 88. 1006-9320-000-015449 89. 1006-9320-000-010685 90. 1006-9321-000-000266 91. 1006-9321-000-019680 92. 1006-9321-000-004778 93. 1006-9321-000-004424 94. 1006-9321-000-008747 95. 1006-9320-000-009249 96. 1006-9320-000-010834 97. 1006-9320-000-022596 98. 1006-9024-000 99. 1006-9026-000 100. 1006-9322-000-011934 101. 1006-9322-000-049412 102. 1006-9322-000-110551 103. 1006-9320-000-019424 104. 1006-9321-000-017187 105. 1006-9321-000-005997 106. 1006-9321-000-091883 107. 1006-9321-000-004524 108. 1006-9321-000-013425 109. 1006-9320-000-015413 110. 1006-9321-000-007378 111. 1006-9320-000-010661 112. 1006-9321-000-005998 113. 1006-9321-000-156642 114. 1006-9320-000-015195 115. 1006-9320-000-017086 116. 1006-9320-000-017852 117. 1006-9321-000-001974 118. 1006-9321-000-010236 119. 1006-9321-000-007641 120. 1006-9321-000-014028 121. 1006-9321-000-015552 122. 1006-9321-000-011524 123. 1006-9321-000-009297 124. 1006-9320-000-017427 125. 1006-9320-000-017498 126. 1006-9321-000-022470 127. 1006-9321-000-024751 128. 1006-9321-000-007642 129. 1006-9321-000-007636 130. 1006-9321-000-029968 131. 1006-9321-000-039161 132. 1006-9321-000-035978 133. 1006-9321-000-011702 134. 1006-9321-000-043612 models truncated

473 devices, in FDA’s words.

Source:

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 1006-9021-000 AMVH00192 1006-9024-000 AMVD00115 1006-9026-000 AMVE00551 1006-9031-000 AMVE00203 1006-9111-000 AMVF01237 1006-9114-000 AMVF00190 1006-9320-000 AMVF01305…

Every code shown here, 1,997 characters

Model, Catalogue or Code # Mfg. Lot or Serial # 1006-9012-000 AMVE00253 1006-9021-000 AMVH00192 1006-9024-000 AMVD00115 1006-9026-000 AMVE00551 1006-9031-000 AMVE00203 1006-9111-000 AMVF01237 1006-9114-000 AMVF00190 1006-9320-000 AMVF01305 1006-9320-000-000001 AMVJ00223 1006-9320-000-000473 AMVH00771 1006-9320-000-000581 AMVJ00239 1006-9320-000-000607 AMVJ00235 1006-9320-000-001101 AMVH00772 1006-9320-000-001211 AMVJ00264 1006-9320-000-002141 AMVJ00336 1006-9320-000-002316 AMVJ00344 1006-9320-000-002368 AMVH00778 1006-9320-000-002450 AMVJ00254 1006-9320-000-002634 AMVH00774 1006-9320-000-003359 AMVJ00316 1006-9320-000-003863 AMVJ00378 1006-9320-000-004311 AMVJ00374 1006-9320-000-004497 AMVJ00408 1006-9320-000-004596 AMVJ00822 1006-9320-000-004623 AMVK00526 1006-9320-000-005394 AMVJ00460 1006-9320-000-005531 AMVJ00486 1006-9320-000-005677 AMVJ00462 1006-9320-000-005868 AMVH00777 1006-9320-000-006392 AMVJ00489 1006-9320-000-006773 AMVK00203 1006-9320-000-006850 AMVJ00537 1006-9320-000-007245 AMVJ00569 1006-9320-000-007380 AMVJ00575 1006-9320-000-007617 AMVJ00576 1006-9320-000-007779 AMVK00110 1006-9320-000-007948 AMVK00137 1006-9320-000-007961 AMVK00169 1006-9320-000-008124 AMVK00124 1006-9320-000-008238 AMVK00130 1006-9320-000-008268 AMVK00131 1006-9320-000-008650 AMVK00145 1006-9320-000-008793 AMVK00157 1006-9320-000-008839 AMVK00241 1006-9320-000-008841 AMVK00160 1006-9320-000-008987 AMVK00197 1006-9320-000-008989 AMVK00194 1006-9320-000-009056 AMVK00214 1006-9320-000-009186 AMVK00226 1006-9320-000-009193 AMVK00245 1006-9320-000-009249 AMVK00138 1006-9320-000-009310 AMVK00257 1006-9320-000-009400 AMVK00254 1006-9320-000-009697 AMVK00271 1006-9320-000-009812 AMVK00270 1006-9320-000-009957 AMVK00278 1006-9320-000-010002 AMVK00324 1006-9320-000-010034 AMVK00315 1006-9320-000-010102 AMVK00322 1006-9320-000-010161 AMVK00332 1006-9320-000-010177 AMVK00314 1006-9320-000-010369 AMVK00392 1006-9320-000-010424 AMVK00390 1006-9320-000-010425 AMVK00388 1006-9320-000-010661…

FDA’s list runs to 14,646 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Source:

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.

Source:

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.
Source:

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.
Source:

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 14,646 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 8, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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