Atlan A350 XL 8621600Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04048675556183), received between Sep 20, 2023 and Mar 30, 2026 — classified as 1 death, 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (11 reports).

4 FDA recall records name this device's identifier, 4 still open.

5 other recalls cover devices cleared under the same FDA submission (K230931); 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.

Recalls naming this device

1. May 7, 2026Class IOpen, Classified

   The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

   Z-2208-2026 · Root cause: Process change control · Recall details · FDA record ↗

2. Sep 9, 2025Class IOpen, Classified

   The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

   Z-2617-2025 · Root cause: Process control · Recall details · FDA record ↗

3. Oct 15, 2024Class IOpen, Classified

   The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

   Z-0305-2025 · Root cause: Process control · Recall details · FDA record ↗

4. Nov 17, 2023Class IIOpen, Classified

   Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.

   Z-0971-2024 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• DeathMar 30, 2026Decrease in Pressure; Inaccurate Delivery; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT EXPIRED DURING SURGERY. THERE IS NO ALLEGED DEVICE MALFUNCTION OR ISSUES WITH THE MACHINE'S PERFORMANCE REPORTED.

  Patient problems: Respiratory Failure

  MAUDE report 24726713 ↗
• MalfunctionMar 24, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE SHUT DOWN DURING A CASE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679622 ↗
• MalfunctionMar 17, 2026Gas Output Problem; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE UNIT FAILED DURING CASE AND THAT THE SCREEN WENT BLANK. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616176 ↗
• MalfunctionNov 26, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  THERE WAS A VENT FAIL DURING USE REPORTED; IT WAS CONFIRMED THAT THE EVENT DID NOT LEAD TO HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655512 ↗
• InjuryAug 25, 2025Decrease in Pressure; Inaccurate Delivery; Gas/Air Leak; Decrease in Pressure; Inaccurate Delivery; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ANY FLOW. THE CASE IN QUESTION WAS REPORTEDLY STARTED WITH MASK VENTILATION AND DURING THIS TIME, THERE WAS NO FLOW WAVEFORM SEEN ON THE DEVICE. THE PATIENT¿S SATS WERE DROPPING AND THEY STARTED TO INTUBATE. ONCE INTUBATED, THEY ATTEMPTED TO VENTILATE BUT AGAIN NO FLOW WAS DETECTED. DURING THIS TIME, THEY STARTED COMPRESSIONS BECAUSE THE PATIENT WAS BECOMING HYPOXIC WHICH CAUSED THE HEART RATE TO DROP. THE DEVICE WAS REPORTEDLY CHECKED AND NO INDICATIONS FOR DEVICE MALFUNCTION WERE FOUND WHICH WOULD EXPLAIN WHY NO FLOW WAS DELIVERED. AS FURTHER REPORTED, THE ONLY ALARM WAS ¿LOW FIO2¿. THEN, THE PHYSICIAN NOTICED THE MISSING CONNECTION OF THE PATIENT AT THE Y-PIECE. ONCE THEY CONNECTED THE CIRCUIT, THE PROBLEM WAS SOLVED. THERE WERE NO FURTHER CONSEQUENCES FOR THE PATIENT REPORTED. BASED ON AVAILABLE INFORMATION, MOST LIKELY AN EXTERNAL LEAKAGE WAS THE ROOT CAUSE. IT CANNOT BE EXCLUDED THAT A USE ERROR CAUSED OR CONTRIBUTED TO THE REPORTED SYMPTOM.

  Patient problems: Bradycardia; Hypoxia

  MAUDE report 22882840 ↗
• MalfunctionJul 31, 2025Use of Device Problem; Failure to Deliver; No Apparent Adverse Event; Use of Device Problem; Failure to Deliver; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE HAD DISCREPANCIES ON O2 READINGS. LOG ANALYSIS REVEALED THAT ALSO A VENTILATOR FAILURE OCCURRED ON THE REPORTED DATE/TIME OF EVENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673712 ↗
• MalfunctionJul 30, 2025Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE A VENTILATOR FAILURE OCCURRED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22661598 ↗
• MalfunctionJul 7, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT THE DEVICE DISPLAYED THE ERROR ¿VENTILATOR FAILURE, PLEASE VENTILATE MANUALLY¿ DURING PC VENTILATION. MANUAL VENTILATION WAS POSSIBLE WITHOUT ANY PROBLEMS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413069 ↗
• MalfunctionMay 28, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT THE DEVICE POSTED AN ALARM FOR A VENTILATION FAILURE. MANUAL VENTILATION WAS POSSIBLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094533 ↗
• MalfunctionMar 27, 2025Gas Output Problem; Incorrect Interpretation of Signal; Failure to Deliver; Gas Output Problem; Incorrect Interpretation of Signal; Failure to Deliver

  IT WAS REPORTED THAT, ON THE (B)(6) 2025, AROUND 16.40 PM, WHILE THE PATIENT WAS ON THE VENTILATOR, THE DEVICE ALARMED FOR A VENTILATOR FAILURE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706770 ↗
• MalfunctionMar 7, 2025Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE STOPPED VENTILATING THE PATIENT DURING A SURGICAL INTERVENTION IN TWO OCCASIONS. ONE ON (B)(6) 2024 AND ONE ON (B)(6) 2024. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545065 ↗
• MalfunctionFeb 19, 2025Incorrect Interpretation of Signal; Use of Device Problem; Failure to Deliver; Incorrect Interpretation of Signal; Use of Device Problem; Failure to Deliver

  IT WAS REPORTED THAT A VENTILATOR FAILURE OCCURRED DURING USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415089 ↗
• MalfunctionFeb 5, 2025Use of Device Problem; Failure to Deliver; Use of Device Problem; Failure to Deliver

  VENT FAIL MESSAGE DURING USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21310013 ↗
• MalfunctionSep 20, 2023Failure to Deliver; Device Handling Problem; Failure to Deliver; Device Handling Problem

  IT WAS REPORTED THAT THE MACHINE FAILED IN THE MIDDLE OF A CASE WITH A "VENTILATOR FAILURE" MESSAGE. THE PROCEDURE WAS FINISHED WITH THE PATIENT BREATHING SPONTANEOUSLY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17779817 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K230931. One submission often covers many models, so check the product and lot details in each record.

• Z-2207-2026 · May 7, 2026 · Open, Classified
  Atlan A350. Model Number: 8211500. anesthesia workstation
• Z-2616-2025 · Sep 9, 2025 · Open, Classified
  Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for u
• Z-0667-2025 · Oct 15, 2024 · Open, Classified
  Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonat
• Z-0668-2025 · Oct 15, 2024 · Open, Classified
  Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neon
• Z-0304-2025 · Oct 15, 2024 · Open, Classified
  Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable