TEC 6 PLUSRecalls & reported problems across all models
Datex-Ohmeda Inc · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one TEC 6 PLUS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 147
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of TEC 6 PLUS by Datex-Ohmeda Inc in the FDA's device registry (GUDID). Together they are named in 147 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2025 and May 28, 2026 — classified as 147 malfunctions.
The most frequently reported specific device problem is “Output below Specifications” (143 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
TEC 6 PLUS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 18, 2024Open, Classified
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Z-0814-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported TEC 6 PLUS problems
Device problems
- Output below Specifications143
- Insufficient Flow or Under Infusion3
- Improper Flow or Infusion1
- Infusion or Flow Problem1
- No Apparent Adverse Event1
- Output above Specifications1
Patient problems
- No Clinical Signs, Symptoms or Conditions147
TEC 6 PLUS models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TEC 6 PLUS VAP DES 120V ESVAPORIZER, ANESTHESIA, NON-HEATED1 recall63 reports
- TEC 6 PLUS VAP DES 220/240V ENVAPORIZER, ANESTHESIA, NON-HEATED1 recall48 reports
- TEC 6 PLUS VAP DES 120V USAVAPORIZER, ANESTHESIA, NON-HEATED36 reports
Recent TEC 6 PLUS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2026Output below Specifications
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT AGENT DELIVERY LESS THAN -20% OF SETTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25325298 ↗MalfunctionMay 12, 2026Output below Specifications
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AGENT DELIVERED LESS THAN 20% FROM SETTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149942 ↗MalfunctionApr 10, 2026Output above Specifications
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AGENT DELIVERED MORE THAN 30% FROM SETTING DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843069 ↗MalfunctionDec 3, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025). THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23701842 ↗MalfunctionNov 13, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543497 ↗MalfunctionOct 31, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23434104 ↗MalfunctionOct 28, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406472 ↗MalfunctionOct 28, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406444 ↗MalfunctionOct 22, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360687 ↗MalfunctionOct 22, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360384 ↗MalfunctionOct 22, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357083 ↗MalfunctionOct 18, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025). THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23332068 ↗MalfunctionOct 17, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325507 ↗MalfunctionOct 17, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325486 ↗MalfunctionOct 17, 2025Output below Specifications; Output below Specifications
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325485 ↗
Other Datex-Ohmeda Inc products
All Datex-Ohmeda Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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