Home › INOVO, INC. › Evolution™
Evolution™
INOVO, INC. · Model OM-900M · UDI-DI 00814470020105
NFB
Prescription
1
510(k) clearances
55
Adverse events (4 deaths)
6
Recalls
16
Facilities
Description
Evolution™ Electronic Oxygen Conserver
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-26 | Inovo, Inc | The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. |
| 2016-06-21 | Invacare Corporation | The rear gradation scale was screen printed upside down on the flowmeter gauge. |
| 2016-06-21 | Invacare Corporation | The rear gradation scale was screen printed upside down on the flowmeter gauge. |
| 2007-10-19 | Superior Products Inc | Leakage: Device was leaking oxygen |
| 2007-01-24 | Sunrise Medical | Cylinder could lose oxygen at high pressure after the filling process |
| 2007-01-24 | Sunrise Medical | Cylinder could lose oxygen at high pressure after the filling process |
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.