Sophysa SA
Country not established
Part of Sophysa
- Devices
- 233
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Sophysa SA makes
Sophysa SA manufactures neurosurgical devices including long-term intracerebral infusion and drainage catheters, cerebrospinal fluid reservoirs, and shunt connectors. Their product portfolio also features ventriculo-peritoneal and atrial shunts, peritoneal and atrial catheters, single-use subcutaneous tunnellers, cerebrospinal fluid shunt valves, and reusable electrical connection cables.
The company is based in the United States, and its devices are categorized as Class I and Class II medical equipment. These products are listed within the FDA 510(k) clearance database and the FDA Unique Device Identification (UDI) system.
Catalogue
Search and filter all 233 devicesShowing 1-50 of 233
FDA recalls
FDA recall records list 1 recall initiated by Sophysa SA, initiated on 2025-11-17. 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 0
- 2025 1
- 2026 0
2025
- 17 Nov 2025 Z-1029-2026 Class II Ongoing Customer complaints of Pressio monitor rebooting.
Frequently asked questions
How many devices does Sophysa SA have in the registry?
The registry currently lists 233 devices for Sophysa SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sophysa SA's devices?
Among its 50 most recently registered devices, Sophysa SA has devices listed in FDA GUDID (50 devices).
What risk classes do Sophysa SA's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Sophysa SA's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sophysa SA?
FDA recall records list 1 recall initiated by Sophysa SA, the most recent initiated on 17 Nov 2025. 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 Sophysa SA in the registry?
The most recently registered devices listed for Sophysa SA include Catheter Extension Cable PSO-EC30, PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP) PSO-MPM01, PRESSIO®3 - PATIENT MONITOR CABLE PHILIPS, AGILENT, MINDRAY 12 pins PSO-MCP01 and PRESSIO®3 - PATIENT MONITOR CABLE DRAEGER, SIEMENS 10 pins PSO-MCP02.