Aladin2 DES SAF-FILRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682100205), received between Apr 22, 2019 and Apr 22, 2019 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K132530); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionApr 22, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 1100-9025-000 ANESTHESIA GAS MACHINE EXPERIENCED A MALFUNCTION RESULTING IN LIGHT ANESTHESIA CAUSING THE PATIENT TO WAKE UP DURING THE PROCEDURE. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE REPORTED EVENT DID INVOLVE A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535647 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132530. One submission often covers many models, so check the product and lot details in each record.

• Z-1562-2016 · Mar 15, 2016 · Terminated
  GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
• Z-1381-2016 · Feb 17, 2016 · Terminated
  GE Healthcare, Aisys CS2 anesthesia..
• Z-0681-2016 · Dec 15, 2015 · Terminated
  GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalat