Full Vision, Inc
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000002038
- Devices
- 6
- Registrations
- EUDAMED
- FDA recalls
- 1414 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
Catalogue
Trackmaster Ref 317-07928
CE MDR EUDAMEDGUDIDTrackmaster Ref 317-07926
CE MDR EUDAMEDGUDIDTrackmaster Ref 317-07927GE
CE MDR EUDAMEDGUDIDTrackmaster Ref 317-07927
CE MDR EUDAMEDGUDIDTrackmaster Ref 317-07926GE
CE MDR EUDAMEDGUDIDTrackmaster Ref 317-07929
CE MDR EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000002038
- DUNS number
- 007237613
- EUDAMED status
- Active
- EUDAMED registered name
- Full Vision, Inc
- EUDAMED abbreviated name
- FVI
- Registered address
- 3017, Full Vision Drive, 67114, Newton, United States
- [email protected]
- PRRC contact
- Doug Pauls
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 7
- 2023 7
- 2024 0
- 2025 0
- 2026 0
2023
- 12 May 2023 Z-2052-2023 Class II Ongoing Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Full distribution text
- 12 May 2023 Z-2053-2023 Class II Ongoing Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Full distribution text
- 12 May 2023 Z-2054-2023 Class II Ongoing Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Full distribution text
- 12 May 2023 Z-2055-2023 Class II Ongoing Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Full distribution text
- 12 May 2023 Z-2056-2023 Class II Ongoing Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Full distribution text
- 12 May 2023 Z-2057-2023 Class II Ongoing Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Full distribution text
- 12 May 2023 Z-2058-2023 Class II Ongoing Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Full distribution text
- 12 May 2023 Z-2052-2023 Class II Ongoing Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
2022
- 31 Aug 2022 Z-0364-2023 Class II Ongoing This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
- 31 Aug 2022 Z-0365-2023 Class II Ongoing This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
- 31 Aug 2022 Z-0366-2023 Class II Ongoing This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
Show all 14 recalls
2022
- 31 Aug 2022 Z-0367-2023 Class II Ongoing This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
- 31 Aug 2022 Z-0368-2023 Class II Ongoing This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
- 31 Aug 2022 Z-0369-2023 Class II Ongoing This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
- 31 Aug 2022 Z-0370-2023 Class II Ongoing This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
Frequently asked questions
How many devices does Full Vision, Inc have in the registry?
The registry currently lists 6 devices for Full Vision, Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Full Vision, Inc's devices?
Among its 6 most recently registered devices, Full Vision, Inc has devices listed in EUDAMED (6 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Full Vision, Inc's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Full Vision, Inc's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Full Vision, Inc?
FDA recall records list 14 recalls initiated by Full Vision, Inc, the most recent initiated on 2023-05-12. 14 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Full Vision, Inc in the registry?
The most recently registered devices listed for Full Vision, Inc include Trackmaster.