Aestiva 7900Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682102308), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (1 report).

26 other recalls cover devices cleared under the same FDA submission (K023366, K172045); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT OXYGEN (O2) CONCENTRATION OR FRESH GAS FLOW. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864284 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023366, K172045. One submission often covers many models, so check the product and lot details in each record.

• Z-3191-2026 · Jul 30, 2026 · Open, Classified
  Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
• Z-3190-2026 · Jul 30, 2026 · Open, Classified
  Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
• Z-3189-2026 · Jul 30, 2026 · Open, Classified
  Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
• Z-3192-2026 · Jul 30, 2026 · Open, Classified
  Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000
• Z-0081-2025 · Jul 12, 2024 · Open, Classified
  Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained
• Z-0076-2025 · Jul 12, 2024 · Open, Classified
  Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals
• Z-0075-2025 · Jul 12, 2024 · Open, Classified
  Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals t
• Z-0082-2025 · Jul 12, 2024 · Open, Classified
  Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals tra
• Z-0077-2025 · Jul 12, 2024 · Open, Classified
  Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals
• Z-0084-2025 · Jul 12, 2024 · Open, Classified
  Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, howev
• Z-0078-2025 · Jul 12, 2024 · Open, Classified
  Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals traine
• Z-0080-2025 · Jul 12, 2024 · Open, Classified
  Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by me
• Z-0074-2025 · Jul 12, 2024 · Open, Classified
  Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory suppo
• Z-1389-2022 · Jun 1, 2022 · Terminated
  GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
• Z-1427-2022 · May 27, 2022 · Open, Classified
  GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

…and 11 more.