Maquet Equipment ARDSAT239022ARecalls & reported problems
Maquet Sas · EQTXHD127 SAT13 · Class 1
All models of Maquet Equipment (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712417246), received between Sep 19, 2023 and Sep 19, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Nov 8, 2023Class IIOpen, Classified
A potential for a light system to fall in the operating room.
Z-0761-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THE FIXING BASE FOR THE MONITOR FROM THE MONITOR HOLDER WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, 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 17771907 ↗
Other Holder, Camera, Surgical devices
- Maquet Equipment ARDSAT239020AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- NA ARDEQT269002AMaquet 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
- Maquet Equipment ARDEQT239026AMaquet 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 · each recall links to the FDA recall notice
- 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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