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U.S. Department of Health and Human Services

Class 2 Device Recall HamiltonG5

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  Class 2 Device Recall HamiltonG5 see related information
Date Initiated by Firm March 24, 2015
Date Posted July 10, 2015
Recall Status1 Terminated 3 on December 23, 2015
Recall Number Z-2057-2015
Recall Event ID 71234
510(K)Number K131774  K103803  
Product Classification Ventilator, continuous, facility use - Product Code CBK
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.
Code Information Software version 2.20 and 2.41,
Recalling Firm/
Manufacturer		 Hamilton Medical, Inc.
4990 Energy Way
Reno NV 89502-4123
For Additional Information Contact Daniel Belanger
800-426-6331 Ext. 215
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action *** Please note *** This is not a new recall. An error occurred, and this recall was originally classified as a class I on July 10, 2015. No further action is required. Hamilton Medical AG notified their customers with a letter dated February 19, 2015 and had a fix (SW 2.42) that was available as of February 20th 2015. Hamilton Medical proceeded to send out notification letters the 24th of March 2015 once they compiled the complete and validated list of customers that had the affected software. Customers with questions were instructed to call 800-426-6331, ext.215.
Quantity in Commerce 248
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CBK and Original Applicant = HAMILTON MEDICAL AG
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