VIASYS Med Systems

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 8

Known Identifiers & Locations

FEI Numbers 3011270181
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (8)

Recall # Product Description Initiation Date Status Action
Z-0001-06 Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090 Reason: The packaging may be compromised such that sterility of the hoods cannot be guaranteed. 2005-09-13 Terminated View Details
Z-0002-06 Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090 Reason: The packaging may be compromised such that sterility of the hoods cannot be guaranteed. 2005-09-13 Terminated View Details
Z-0033-04 Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2 Reason: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up. 2003-09-10 Terminated View Details
Z-0034-04 Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24 Reason: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up. 2003-09-10 Terminated View Details
Z-0035-04 Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24 Reason: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up. 2003-09-10 Terminated View Details
Z-0036-04 Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120 Reason: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up. 2003-09-10 Terminated View Details
Z-0037-04 Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166 Reason: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up. 2003-09-10 Terminated View Details
Z-0038-04 Sideport Kit w/Oxygen Line, consisting of an adjustable sideport valve, an O2 port elbow and O2 supply tubing; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83167 Reason: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up. 2003-09-10 Terminated View Details

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