Viasys Medsystems
Country not established
- Devices
- 7
- FDA recalls
- 8
At a glance
Market reach
- United States
- FDA recalls
What Viasys Medsystems makes
Viasys Medsystems manufactures enteral access devices and feeding systems, including the Cortrak enteral access device and its modifications, enteral pump sets, and an anti-IV enteral feeding system. The company also produces surgical helmet systems, such as the Stackhouse Freedomaire II, designed for intraoperative patient protection. Additionally, it supplies disposable pressure manometers, like the Pulmanex model, for respiratory monitoring.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
Cortrak Enteral Access Device, Model 20-0900 Ref K063061
Regimes: 510(k) Registry: 510(k)Enteral Pump Set, Model 20-1010 Ref K081725
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Cortrak Ref K041987
Regimes: 510(k) Registry: 510(k)Anti-I.V. Enteral Feeding System Ref K043044
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 8 recalls initiated by Viasys Medsystems, the earliest on 2003-09-10 and the most recent on 2005-09-13. By recorded status: 8 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 13 Sep 2005 Z-0001-06 Unclassified (pre-2012) Terminated The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
- 13 Sep 2005 Z-0002-06 Unclassified (pre-2012) Terminated The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
2003
- 10 Sep 2003 Z-0033-04 Unclassified (pre-2012) Terminated The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
Full distribution text
- 10 Sep 2003 Z-0034-04 Unclassified (pre-2012) Terminated The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
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- 10 Sep 2003 Z-0035-04 Unclassified (pre-2012) Terminated The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
Full distribution text
- 10 Sep 2003 Z-0036-04 Unclassified (pre-2012) Terminated The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
Full distribution text
- 10 Sep 2003 Z-0037-04 Unclassified (pre-2012) Terminated The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
Full distribution text
- 10 Sep 2003 Z-0038-04 Unclassified (pre-2012) Terminated The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
Full distribution text
- 10 Sep 2003 Z-0033-04 Unclassified (pre-2012) Terminated The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
Frequently asked questions
How many devices does Viasys Medsystems have in the registry?
The registry currently lists 7 devices for Viasys Medsystems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Viasys Medsystems's devices?
Among its 7 most recently registered devices, Viasys Medsystems has devices listed in FDA 510(k) (7 devices).
What risk classes do Viasys Medsystems's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Viasys Medsystems's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Viasys Medsystems?
FDA recall records list 8 recalls initiated by Viasys Medsystems, the most recent initiated on 13 Sep 2005. 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 Viasys Medsystems in the registry?
The most recently registered devices listed for Viasys Medsystems include CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900, ENTERAL PUMP SET, MODEL 20-1010, STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 and MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900.