Harvard Clinical Technology
Country not established
- Devices
- 2
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Harvard Clinical Technology makes
Harvard Clinical Technology manufactures syringe pumps, including the Harvard 1 Syringe Pump (with and without Patient-Controlled Analgesia functionality) and the Harvard 2 Syringe Pump (Model 2001-001). These devices are designed for controlled infusion of fluids in clinical settings, such as hospitals and medical facilities.
The company’s syringe pumps are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The portfolio is regulated in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Harvard 2 Syringe Pump, Model 2001-001 Ref K050107
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Harvard Clinical Technology, the earliest on 2003-08-11 and the most recent on 2004-11-03. By recorded status: 4 terminated. 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.
2004
- 3 Nov 2004 Z-0431-05 Unclassified (pre-2012) Terminated Potential pump motor/encoder assembly failure may cause over infusing medication in patients
- 3 Nov 2004 Z-0432-05 Unclassified (pre-2012) Terminated Potential pump motor/encoder assembly failure may cause over infusing medication in patients
- 3 Nov 2004 Z-0433-05 Unclassified (pre-2012) Terminated Potential pump motor/encoder assembly failure may cause over infusing medication in patients
2003
- 11 Aug 2003 Z-1208-03 Unclassified (pre-2012) Terminated Under specific sequence conditions, the unit may apper to be infusing, but is not
Frequently asked questions
How many devices does Harvard Clinical Technology have in the registry?
The registry currently lists 2 devices for Harvard Clinical Technology. Devices recorded under merged duplicate company entries are counted once.
Which registries list Harvard Clinical Technology's devices?
Among its 2 most recently registered devices, Harvard Clinical Technology has devices listed in FDA 510(k) (2 devices).
What risk classes do Harvard Clinical Technology's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Harvard Clinical Technology's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Harvard Clinical Technology?
FDA recall records list 4 recalls initiated by Harvard Clinical Technology, the most recent initiated on 3 Nov 2004. 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 Harvard Clinical Technology in the registry?
The most recently registered devices listed for Harvard Clinical Technology include HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP and HARVARD 2 SYRINGE PUMP, MODEL 2001-001.