Aladin2 SEV QUIK-FILRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840682100250), received between Aug 6, 2025 and Jun 18, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT AGENT DELIVERY LESS THAT -20% OF SETTING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547815 ↗
• MalfunctionAug 22, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT AGENT DELIVERY LESS THAT -20% OF SETTING DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872254 ↗
• MalfunctionAug 12, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN 'AGENT % ZERO' ERROR CAUSING NO OUTPUT WHILE IN USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784621 ↗
• MalfunctionAug 6, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN NO OUTPUT DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734120 ↗

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