Seer Medical Pty, Ltd.
AustraliaFDA applicant, unverified
- Devices
- 1
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Seer Medical Pty, Ltd. makes
Seer Medical Pty, Ltd. manufactures the Seer Home, a medical device designed for remote patient monitoring and telehealth applications, enabling continuous health data collection and transmission for clinical assessment.
The Seer Home is classified as a Class II device under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
Seer Home Ref K212788
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Seer Medical Pty, Ltd., initiated on 2024-08-12. By recorded status: 1 ongoing. The reasons filed fall into these groups: other reasons as filed. 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 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 12 Aug 2024 Z-3143-2024 Class II Ongoing During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues. - Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2 - Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls - Seer Home Systems were distributed with labeling deficiencies
Frequently asked questions
How many devices does Seer Medical Pty, Ltd. have in the registry?
The registry currently lists 1 device for Seer Medical Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seer Medical Pty, Ltd.'s devices?
Among its 1 most recently registered device, Seer Medical Pty, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Seer Medical Pty, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Seer Medical Pty, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Seer Medical Pty, Ltd.?
FDA recall records list 1 recall initiated by Seer Medical Pty, Ltd., the most recent initiated on 12 Aug 2024. 1 of them is 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 Seer Medical Pty, Ltd. in the registry?
The most recently registered devices listed for Seer Medical Pty, Ltd. include Seer Home.