Atlan A350 8621500Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 04048675556176), received between Oct 17, 2023 and Sep 25, 2026 — classified as 2 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (42 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 7, 2026Open, 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-2207-2026 · Root cause: Process change control · FDA record ↗

2. Sep 9, 2025Open, Classified

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

   Z-2616-2025 · Root cause: Process control · FDA record ↗

3. Oct 15, 2024Open, 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-0304-2025 · Root cause: Process control · FDA record ↗

4. Nov 17, 2023Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Incorrect Interpretation of Signal; Use of Device Problem

  It was reported that the device stopped ventilation during operation. Manual ventilation was possible. No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894920 ↗
• MalfunctionJul 16, 2026No Device Output; Failure to Deliver

  It was reported that the anesthesia machine malfunctioned during operation. The monitor became inoperable (black screen) and ventilation failed. The patient could be ventilated without difficulty using a manual resuscitation bag. No patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841824 ↗
• InjuryJun 12, 2026Decrease in Pressure; Inaccurate Delivery; Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A CARDIAC ARREST DURING A SURGICAL PROCEDURE. THE USERS DID NOT ALLEGE A DEVICE MALFUNCTION AND ADMITTED THAT THEY DID NOT RECOGNIZE THE ALARMS THE DEVICE HAD POSTED DURING THE COURSE OF EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 25483760 ↗
• MalfunctionApr 8, 2026Gas Output Problem; Decrease in Pressure

  IT WAS REPORTED THAT THE ATLAN A350 WAS USED TO PROVIDE ANESTHESIA FOR A NEONATAL PATIENT (UNDER 5 KG) IN PC VENTILATION MODE WITH THE FOLLOWING PARAMETERS: PINSP APPROXIMATELY 20¿25, AND ACHIEVED VTE AROUND 16¿18 ML. AFTER APPROXIMATELY 15¿20 MINUTES OF ANESTHESIA, THE VTE PARAMETER WAS NO LONGER DISPLAYED AND AN ¿APNEA (NO FLOW)¿ ALARM WAS TRIGGERED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814515 ↗
• MalfunctionMar 4, 2026No Device Output

  IT WAS REPORTED THAT THE DEVICE SUDDENLY FAILED DURING VENTILATION IN PSV-MODE, SCREEN WAS BLACK. EMERGENCY VENTILATION WAS INITIATED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505180 ↗
• MalfunctionNov 7, 2025Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23495198 ↗
• MalfunctionSep 22, 2025Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver

  IT WAS REPORTED THAT AFTER APPROXIMATELY 30 MINUTES OF VENTILATION, THE DEVICE DISPLAYED VENTILATOR FAILURE AND EMERGENCY INTAKE. IT WAS SWITCHED TO STANDBY MODE AND AFTER A WHILE IT STARTED WORKING AGAIN AND CONTINUED TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23107512 ↗
• MalfunctionSep 17, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, MANUAL VENTILATION WAS PERFORMED, FOLLOWED BY A SWITCH TO AUTOMATIC VENTILATION. AFTER APPROXIMATELY TWO MINUTES, THE ATLAN A350 ALARMED A VENTILATOR FAILURE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072337 ↗
• MalfunctionSep 12, 2025Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver

  IT WAS REPORTED THAT TOWARDS THE END OF CLOSING WOUND, THERE WAS AN UNUSUAL NOISE FROM THE DEVICE AND THE MECHANICAL VENTILATION STOPPED. MANUAL VENTILATION WAS INITIATED, AND THE OPERATION WAS COMPLETED SAFELY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035223 ↗
• MalfunctionSep 3, 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 A VENTILATOR FAILURE DURING USE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952195 ↗
• MalfunctionSep 3, 2025Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951122 ↗
• MalfunctionAug 28, 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 POSTED A VENTILATOR FAILURE ALARM DURING USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910735 ↗
• MalfunctionAug 28, 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 POSTED A VENTILATOR FAILURE ALARM DURING USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910734 ↗
• MalfunctionAug 19, 2025Degraded; Gas Output Problem; Material Split, Cut or Torn; Degraded; Gas Output Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025 AT AROUND 14:26 P.M., A FEW MINUTES AFTER THE START OF SURGERY DURING A CARDIAC PROCEDURE, THE ANAESTHESIA MACHINE FAILED DURING OPERATION. THE ALARM WAS RAISED WITH "VENTILATOR FAILURE", THE ANAESTHESIA MACHINE WAS SWITCHED TO MANUEL MODE WITHOUT ANY PROBLEMS AND THEN THE ANAESTHESIA MACHINE WAS BACK IN OPERATION WITHOUT ANY PROBLEMS. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840581 ↗
• MalfunctionJul 25, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THERE WAS A FAILURE OF THE VENTILATOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607347 ↗
• MalfunctionJul 24, 2025Failure to Analyze Signal; Activation Failure; Failure to Analyze Signal; Activation Failure

  IT WAS REPORTED THAT A VENTILATOR FAILURE OCCURRED ON (B)(6) 2025 DURING AN OPERATION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585675 ↗
• MalfunctionJul 8, 2025Gas Output Problem; Decrease in Pressure; Inaccurate Delivery; Gas/Air Leak; Gas Output Problem; Decrease in Pressure; Inaccurate Delivery; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS CHANGED FROM MAN/SPON MODE TO PSV, WHICH POP UP WITH ALARMS, FRESH GAS LOW/LEAKAGE, AIR INLET ACTIVATED ALARM AND NO VENTILATION WAS HAPPENING. THE ANESTHETIC SWITCH BACK TO MAN/SPON AND THEN TRIED VC MODE AND THE VENTILATOR WAS NOT FUNCTIONAL, AND NO PISTON MOVEMENT WAS OBSERVED. THIS CHANGING OF MODES TRIED FEW TIMES, BUT THE VENTILATOR FAILED TO RESPOND WITHOUT ANY ALARM IN VC MODE. THE CASE WAS COMPLETED WITH MAN/SPON EMERGENCY VENTILATION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438817 ↗
• MalfunctionJul 7, 2025Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Activation Failure; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Activation Failure

  IT WAS REPORTED THAT THE MESSAGE "VENTILATOR FAILURE!!!" WAS DISPLAYED DURING OPERATION. THE DEVICE WAS REPLACED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413071 ↗
• MalfunctionJul 4, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT THE ATLAN THERAPY WASN'T IMPROVING THE PATIENTS CONDITION SO THERE ARE POSSIBLY 2X DISCONNECTS FROM THE ATLAN TO HAMILTON -T1 VENTILATORS, THEN A RECONNECTION TO THE ATLAN. THERE WERE A NUMBER OF ALARMS WHICH WOULD BE ASSOCIATED WITH NO MANSPONT FLOW. THERE WAS ALSO A VENTILATOR FAIL ALARM. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402918 ↗
• MalfunctionJun 24, 2025Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Activation Failure; Gas Output Problem; Failure to Analyze Signal; Failure to Deliver; Activation Failure

  IT WAS REPORTED THAT THE DEVICE WHILE CONNECTED TO A PATIENT, GAVE A VENTILATION MOTOR FAILURE ALARM AND THEN CHANGED INTO SAFETY MODE. THE SURGERY WAS CONCLUDED WITHOUT ANY INCIDENCE WITH THE DEVICE IN MANUAL MODE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317704 ↗
• MalfunctionJun 19, 2025Gas Output Problem; Decrease in Pressure; Appropriate Device Problem Term/Code Not Available; Intermittent Communication Failure; Gas Output Problem; Decrease in Pressure; Appropriate Device Problem Term/Code Not Available; Intermittent Communication Failure

  IT WAS REPORTED THAT THE ATLAN HAS BEEN DISPLAYING ERROR CODES WHILE IN USE (ERR MESSAGES IN DISPLAY), AND THE UNIT WAS REPORTED TO HAVE SHUTDOWN DOWN LATE YESTERDAY AFTER DISPLAYING ERR, DISPLAY WENT BLACK AND THE UNIT SHUTDOWN. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288925 ↗
• MalfunctionJun 12, 2025Gas Output Problem; Use of Device Problem; Gas Output Problem; Use of Device Problem

  IT WAS REPORTED THAT THE EQUIPMENT FAILED DURING VENTILATION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192521 ↗
• MalfunctionJun 4, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT AT AROUND 9.38 P.M., THE ANAESTHESIA MACHINE FAILED DURING AN EMERGENCY PROCEDURE WITH HEART LUNG MACHINE INVOLVEMENT IN HCH OPERATING ROOM 2. "VENTILATOR FAILURE" ... CHANGEOVER OF THE ANESTHESIA MACHINE TO MANUEL MODE WITHOUT PROBLEMS AND SUBSEQUENT START-UP OF ANOTHER VENTILATOR IN ORDER TO CONTINUE MECHANICAL VENTILATION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140794 ↗
• MalfunctionMay 28, 2025Gas Output Problem; Inaccurate Delivery; Output Problem; Physical Resistance/Sticking; Gas Output Problem; Inaccurate Delivery; Output Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE FAILED DURING OPERATION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094356 ↗
• InjuryMay 28, 2025Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information

  IT WS REPORTED THAT THERE WAS AN INCIDENT WITH PATIENT INJURY DURING A TREATMENT ON (B)(6) 2024. ACCORDING TO INITIAL INFORMATION, THE INCIDENT OCCURRED DURING THE INDUCTION OF ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 22094355 ↗

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-2208-2026 · May 7, 2026 · Open, Classified
  Atlan A350XL. Model Number: 8621600. anesthesia workstation
• Z-2617-2025 · Sep 9, 2025 · Open, Classified
  Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for
• 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-0305-2025 · Oct 15, 2024 · Open, Classified
  Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
• 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