NA ARDSAT209001ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700712401283), received between Sep 12, 2023 and Mar 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Device Dislodged or Dislocated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE SURGICAL EQUIPMENT - EQT. AS REPORTED, THE SPRING ARM DID NOT MAINTAIN ITS POSITION AND HIT A NURSE¿S HEAD. NO INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. HOWEVER, WE DECIDED TO REPORT THE ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS THE DEVICE HITTING PERSONNEL COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673604 ↗
• MalfunctionSep 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MANUFACTURER'S REFERENCE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728416 ↗