Aeris Evo
Aeris Evo Ventilator
1manufacturer
1catalogue number
5recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | NOU |
| Device type | Continuous, Ventilator, Home Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2021-03-19 |
| Record revised | 2021-04-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F; Storage environment humidity 5 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Aeris Evo Ventilator | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vivo 50 | Breas Medical, Inc. | 17 |
| Patient Circuit | Flight Medical Innovations Ltd. | 13 |
| Astral | Resmed PTY Ltd. | 12 |
| Trilogy Evo | Respironics Inc. | 10 |
| Trilogy | Respironics Inc. | 10 |
| Care Orchestrator | Respironics Inc. | 10 |
| Trilogy 200 | Respironics Inc. | 5 |
| Continuous Ventilator | Flight Medical Innovations Ltd. | 3 |
| Trilogy 100 | Respironics Inc. | 3 |
| Vocsn Roll Stand | Ventec Life Systems, Inc. | 2 |
| Sensor | Respironics Inc. | 2 |
| Astral Double Limb Kit | Resmed PTY Ltd. | 1 |
Showing 12 of 28. All products under Continuous, Ventilator, Home Use
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-07-16 | Class I | Device Design | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. | 90,910 US; 56,273 ROW |
| 2024-07-16 | Class I | Device Design | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. | 90,910 US; 56,273 ROW |
| 2021-07-26 | Class II | Labeling design | Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure Increase” and the second issue is described as “Pressure Drift (Continuous Usage | 18936 (US); 4659 (OUS) |
| 2021-07-26 | Class II | Labeling design | Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure Increase” and the second issue is described as “Pressure Drift (Continuous Usage | 18588 (US); 5662 (OUS) |
| 2021-07-26 | Class II | Labeling design | Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure Increase” and the second issue is described as “Pressure Drift (Continuous Usage | 101 (FEMA Stockpile Only); 21077 (OUS) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.