Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check, low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected, it will result in fresh gas leaking to |
| Product | Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold. |
| Quantity | 31,443 devices (23,947 US, 7496 OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CROATIA local name-Hrvatska, CYPRUS, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA-REPUBLIC OF, KUWAIT, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY… |
| Initiated | 2013-07-29 |
| Classified | 2013-09-06 |
| Terminated | 2015-04-17 |
| Recall number | Z-2161-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-2161-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65970/
Alerts for GE HealthCare Technologies Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.