Maquet Equipment ARDSAT239019ARecalls & reported problems
Maquet Sas · EQTXHS021 SAT12 · Class 1
All models of Maquet Equipment (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700712416096), received between Jun 5, 2023 and Dec 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Detachment 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 23876021 ↗MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON 29TH MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT ¿ EQTXHS021 SAT12. IT WAS STATED THE HANDLE HAS COME OFF FROM THE MONITOR HOLDER DURING SURGERY. IT WAS CONFIRMED THERE WAS NO HARM TO A PATIENT'S HEALTH. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17066633 ↗
Other Holder, Camera, Surgical devices
- Maquet Equipment ARDSAT239020AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- NA ARDEQT269002AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- Maquet Equipment ARDSAT239022AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- Maquet Equipment ARDEQT239016AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- Maquet Equipment ARDSAT239007AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- Maquet Equipment ARDEQT639023AMaquet Sas · HOLDER, CAMERA, SURGICAL1 recall0 reports
- Maquet Equipment ARDSAT639005AMaquet Sas · HOLDER, CAMERA, SURGICAL1 recall0 reports
- Maquet Equipment ARDSAT639019AMaquet Sas · HOLDER, CAMERA, SURGICAL1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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