HarmonyAIR Monitor Carrier (REF HCLP160001)Recalls & reported problems
Steris Corporation · The HarmonyAIR Monitor Carrier Large Format Standard, Low Profile, 1600mm Arm is a monitor mounting system designed for complex procedural environments. · Class 1
All models of HarmonyAIR (240)
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 00724995153472), received between Oct 6, 2023 and Nov 10, 2023 — 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.
MalfunctionNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A CAP COVER FROM THEIR HARMONYAIR MONITOR CARRIER DETACHED AND FELL INTO THE STERILE FIELD SUBSEQUENTLY CAUSING A PROCEDURE DELAY. THE STERILE FIELD WAS REESTABLISHED, AND THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18112244 ↗MalfunctionOct 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE PLASTIC COVER TO THEIR HARMONYAIR MONITOR CARRIER FELL OFF DURING USE. NO REPORT OF PROCEDURE DELAYS/CANCELLATIONS. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17884983 ↗
Other TABLE, OPERATING-ROOM, AC-POWERED devices
- ORT300 TableIMRIS Imaging, Inc. · Table, Operating-Room, Ac-Powered2 recalls21 reports
- ORT200 TableIMRIS Imaging, Inc. · Table, Operating-Room, Ac-Powered2 recalls12 reports
- MEERA mobile operating table 720001F2MAQUET GmbH · TABLE, OPERATING-ROOM, AC-POWERED2 recalls0 reports
- HarmonyAIR A-Series Suspension SystemSteris Corporation · TABLE, OPERATING-ROOM, AC-POWERED2 recalls0 reports
- HarmonyAIR A-Series Suspension SystemSteris Corporation · TABLE, OPERATING-ROOM, AC-POWERED2 recalls0 reports
- HarmonyAIR A-Series Suspension SystemSteris Corporation · TABLE, OPERATING-ROOM, AC-POWERED2 recalls0 reports
- MEERA mobile operating table 720001B2MAQUET GmbH · TABLE, OPERATING-ROOM, AC-POWERED1 recall19 reports
- MAGNUS operating table system 118001B2MAQUET GmbH · TABLE, OPERATING-ROOM, AC-POWERED1 recall17 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.
How reports and recalls are matched · Editorial policy · Report an error on this page