Home › PENLON LTD › Penlon
Penlon
PENLON LTD · Model Sigma Delta Vaporizer / Isoflurane · UDI-DI 05051977002011
CAD
Prescription
1
510(k) clearances
4,533
Adverse events (2 deaths)
13
Recalls
13
Facilities
Description
Sigma Delta Vaporizer / Isoflurane
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-24 | Draeger, Inc. | A certain component of affected devices was not delivered within specification and contained impurities. |
| 2025-11-24 | Draeger, Inc. | A certain component of affected devices was not delivered within specification and contained impurities. |
| 2024-11-18 | GE Medical Systems, LLC | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2024-11-18 | GE Medical Systems, LLC | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2024-11-18 | GE Medical Systems, LLC | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2024-11-18 | GE Medical Systems, LLC | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2024-11-18 | GE Medical Systems, LLC | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2017-10-04 | GE Healthcare, LLC | Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. |
| 2016-04-21 | Draeger Medical, Inc. | Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. I |
| 2013-05-14 | Penlon, Ltd. | It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.