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U.S. Department of Health and Human Services

Class 2 Device Recall HamiltonG5 Ventilator

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 Class 2 Recall
HamiltonG5 Ventilator
see related information
Date Posted April 08, 2011
Recall Status1 Terminated on March 21, 2012
Recall Number Z-1928-2011
Recall Event ID 58014
Premarket Notification
510(K) Number
K081521 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
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.
Code Information Software version V2.00x and Neonatal Option or V2.01x and Neonatal software
Recalling Firm/
Manufacturer
Hamilton Medical Inc
4990 Energy Way
P O Box 30008
Reno, Nevada 89502-3008
For Additional Information Contact Dan 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
DESIGN: Software Design
Action A 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 Commerce 97 units
Distribution Nationwide Distribution -- MA, FL, GA, NC, MI, NC, MO, TX, and WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = HAMILTON MEDICAL AG
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