# FDA recall Z-0117-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-07-19.

## Product

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.	

## 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

Worldwide

## Key facts

- **Recall number:** Z-0117-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-19
- **Report date:** 2019-12-25
- **Termination date:** 2026-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2020

## Citation

> AI Analytics. FDA recall Z-0117-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0117-2020. Source: US FDA. Licensed CC0.

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