Life2000
LIFE2000 Ventilator
1manufacturer
1catalogue number
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 | Welch Allyn, 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 |
| Record published | 2024-05-09 |
| Record revised | 2026-02-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS-01-0118 | Withdrawn |
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 Naming This Product
10 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2025-04-07 | Class I | Software in the Use Environment | A cybersecurity vulnerability was discovered through internal testing. | 4881 units |
| Baxter Healthcare Corporation | UDI-DI | 2024-12-20 | Class I | Process control | There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. | 946 units |
| Baxter Healthcare Corporation | UDI-DI | 2024-12-20 | Class I | Process control | There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. | 1 unit |
| Baxter Healthcare Corporation | UDI-DI | 2024-12-20 | Class I | Process control | There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. | 1 unit |
| Baxter Healthcare Corporation | UDI-DI | 2024-09-12 | Class I | Software Design Change | The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy. | 10,957 units |
| Baxter Healthcare Corporation | UDI-DI | 2024-05-29 | Class I | Under Investigation by firm | Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator’s internal battery f | 2,510 units |
| Baxter Healthcare Corporation | UDI-DI | 2023-01-25 | Class I | Under Investigation by firm | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. | 4279 units |
| Baxter Healthcare Corporation | UDI-DI | 2023-01-25 | Class I | Under Investigation by firm | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. | 135 units |
| Baxter Healthcare Corporation | UDI-DI | 2023-01-25 | Class I | Under Investigation by firm | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. | 8 units |
| Baxter Healthcare Corporation | UDI-DI | 2023-01-25 | Class I | Under Investigation by firm | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. | 71 units |
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.