Company: Hamilton Medical Inc
Date of Enforcement Report 4/20/2011
Class ll:

PRODUCT
Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical Intended for use in the hospital and institutional environment where healthcare professionals provide patient care. Recall # Z-1928-2011

REASON
The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator..

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hamilton Medical Inc., Reno, NV, by letter on February 16, 2011.
Manufacturer: Hamilton Medical AG, Bonaduz, Switzerland. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
97 units

DISTRIBUTION
MA, FL, GA, NC, MI, MO, TX, WV