Forte Automation Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Forte Automation Systems, Inc. makes
Forte Automation Systems, Inc. manufactures patient positioning systems designed to assist in precise and controlled placement of patients during medical procedures, ensuring alignment and stability for clinical workflows.
The company’s portfolio is regulated under FDA Class II devices and is listed in the 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Patient Positioning System Ref K170502
510(k) 510(k)Patient Positioning System Ref K122413
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Forte Automation Systems, Inc., initiated on 2017-09-05. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 5 Sep 2017 Z-2537-2018 Class II Terminated Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
Frequently asked questions
How many devices does Forte Automation Systems, Inc. have in the registry?
The registry currently lists 2 devices for Forte Automation Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Forte Automation Systems, Inc.'s devices?
Among its 2 most recently registered devices, Forte Automation Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Forte Automation Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Forte Automation Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Forte Automation Systems, Inc.?
FDA recall records list 1 recall initiated by Forte Automation Systems, Inc., the most recent initiated on 2017-09-05. 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 Forte Automation Systems, Inc. in the registry?
The most recently registered devices listed for Forte Automation Systems, Inc. include Patient Positioning System.