AriaTele 96281Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841522100352), received between Jan 9, 2026 and Feb 20, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K121480); 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Device Alarm System

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REQUEST REPAIR FOR AN ARIATELE THAT FAILED TO ALARM. NO PATIENT OR USER HARM WAS REPORTED. SPACELABS HEALTHCARE TECHNICAL SUPPORT ATTEMPTED TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION REGARDING REPORTED FAILURE TO ALARM, HOWEVER THE CUSTOMER HAS NOT RESPONDED TO ATTEMPTS TO GET ADDITIONAL INFORMATION. THE DEVICE HAS BEEN RECEIVED, HOWEVER HAS NOT YET BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408320 ↗
• InjuryFeb 2, 2026Off-Label Use

  THE CUSTOMER REPORTED TO SPACELABS HEALTHCARE THAT A PATIENT INCIDENT OCCURRED WITH AN ARIATELE DEVICE. DURING THE EVENT, THE PATIENT APPEARED TO BE HYPOXIC DESPITE NO INDICATIONS OF LOW OXYGEN SATURATION BY THE ARIATELE. THIS WAS NOTICED BY CLINICAL STAFF AND A SECONDARY HANDHELD PULSE OXIMETER WAS USED TO CONFIRM THE PATIENT WAS HYPOXIC. TREATMENT WAS ADMINISTERED AND THE PATIENT SURVIVED. DURING TROUBLESHOOTING, THE TECHNICAL SUPPORT REPRESENTATIVE CONFIRMED THAT THE CUSTOMER WAS USING AN SP02 SENSOR WHICH IS NOT COMPATIBLE WITH THE ARIATELE TRANSMITTER. THE CUSTOMER WAS PROVIDED DOCUMENTATION THAT STATES THE SENSOR WAS INCOMPATIBLE AND TO ONLY USE APPROVED SENSORS GOING FORWARD. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE USE OF INCOMPATIBLE SP02 SENSORS WHICH PROVIDED INACCURATE RESULTS.

  Patient problems: Hypoxia

  MAUDE report 24229104 ↗
• MalfunctionJan 9, 2026Device Alarm System

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT THEY HAD AN ARIATELE TRANSMITTER THAT HAD AN ALARM THAT WAS NOT WORKING PROPERLY. SPACELABS HEALTHCARE TECHNICAL SUPPORT MADE SEVERAL ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE ALARM ISSUE; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE. THE CUSTOMER SHIPPED THE DEVICE TO SPACELABS HEALTHCARE FOR DEPOT REPAIR. THE UNIT WAS TESTED BY AN EQUIPMENT SERVCE CENTER TECHNICIAN. THE TECHNICIAN COULD NOT VERIFY THE PROBLEM OF 'WILL NOT ALARM' BECAUSE THE DEVICE IS NOT CAPABLE OF PRODUCING ALARMS. HOWEVER, DID VERIFY A DISPLAY RELATED FAILURE. THE UNIT HAD A FAULTY DISPLAY PCB CAUSING A BLANK SCREEN AND DAMAGE TO THE CASE. THE UNIT WAS REPAIRED AND AFTER PASSING ALL FINAL FUNCTIONAL TESTING, THE UNIT WAS RETURNED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031212 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121480. One submission often covers many models, so check the product and lot details in each record.

• Z-2586-2014 · Jul 2, 2014 · Terminated
  ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
• Z-0871-2014 · Dec 19, 2013 · Terminated
  ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.