Company: Hamilton Medical.
Date of Enforcement Report 8/5/2015
Class lI:
PRODUCT
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients. Recall Number Z-2057-2015
REASON
Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
RECALLING FIRM/MANUFACTURER
Hamilton Medical Inc., Reno NV 3/24/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
248
DISTRIBUTION
Nationwide
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