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U.S. Department of Health and Human Services

Class 2 Device Recall HamiltonG5 Ventilator

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 Class 2 Device Recall HamiltonG5 Ventilatorsee related information
Date Initiated by FirmFebruary 16, 2011
Date PostedApril 08, 2011
Recall Status1 Terminated 3 on March 21, 2012
Recall NumberZ-1928-2011
Recall Event ID 58014
510(K)NumberK081521 
Product Classification Facility Use Continuous Ventilator - Product Code CBK
ProductHamilton-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.
Code Information Software version V2.00x and Neonatal Option or V2.01x and Neonatal software
FEI Number 2937708
Recalling Firm/
Manufacturer		 Hamilton Medical Inc
4990 Energy Way
P O Box 30008
Reno NV 89502-3008
For Additional Information ContactDan Belanger
800-426-6331 Ext. 215
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionA Medical device Safety Alert and Corrective Action along with a cover letter, was sent to all locations on February 16, 2011. The letter identified the affected product along with the reason for recall. The letter states that operators deactivate the "high tidal volume" alarm as described in appendix K.4 of the operator's manual until the ventilator is upgraded with a corrected software. Distributors will upgrade the affected devices with the corrected software as soon as possible. Questions can be directed to 800-426-6331, ext 215.
Quantity in Commerce97 units
DistributionNationwide Distribution -- MA, FL, GA, NC, MI, NC, MO, TX, and WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CBK
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