# FDA recall Z-0116-2020

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

## Product

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.	1009-9

## 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-0116-2020
- **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-0116-2020

## Citation

> AI Analytics. FDA recall Z-0116-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0116-2020. Source: US FDA. Licensed CC0.

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