Delphi Medical Systems
Country not established
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Delphi Medical Systems makes
Delphi Medical Systems manufactures infusion pumps and administration sets, specifically the DELPHI INFUSION PUMP and DELPHI ADMINISTRATION SET MODEL IV-01000/IV-02XXXX, as well as portable oxygen concentrators, such as the MODEL RS-00400.
The company's devices are classified as Class II and listed in the FDA 510(k) registry. Delphi Medical Systems is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Portable Oxygen Concentrator, Model Rs-00400 Ref K073242
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Delphi Medical Systems, initiated on 2006-03-29. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 29 Mar 2006 Z-1445-06 Unclassified (pre-2012) Terminated Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.
Frequently asked questions
How many devices does Delphi Medical Systems have in the registry?
The registry currently lists 2 devices for Delphi Medical Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Delphi Medical Systems's devices?
Among its 2 most recently registered devices, Delphi Medical Systems has devices listed in FDA 510(k) (2 devices).
What risk classes do Delphi Medical Systems's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Delphi Medical Systems's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Delphi Medical Systems?
FDA recall records list 1 recall initiated by Delphi Medical Systems, the most recent initiated on 2006-03-29. 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 Delphi Medical Systems in the registry?
The most recently registered devices listed for Delphi Medical Systems include DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) and PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400.