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U.S. Department of Health and Human Services

Class 2 Device Recall HAMILTONC6 Intensive Care

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  Class 2 Device Recall HAMILTONC6 Intensive Care see related information
Date Initiated by Firm March 14, 2023
Date Posted April 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-1429-2023
Recall Event ID 91925
510(K)Number K201658  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product HAMILTON-C6, REF: 160021
Code Information Software Version: 1.2.1, UDI-DI: 07630002808590
Recalling Firm/
Manufacturer		 Hamilton Medical AG
Via Crusch 8
Bonaduz Switzerland
For Additional Information Contact
41816606010
Manufacturer Reason
for Recall		 Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.
FDA Determined
Cause 2		 Software design
Action On 3/14/23, correction notices were emailed to health care facilities and distribution partners. Customers were told the following: 1) Firm will reach out to schedule the software update. 2) See Operation's Manual, Section 7.7, Safety Ventilation. The device must turn off to exit Safety Ventilation. 3) Complete and return the confirmation form to bret.everett@hamiltonmedical.com 4) If the malfunction occurs take the following actions: a) Monitor your patient. b) Provide an alternative device for ventilation. c) Have the ventilator serviced. If you have questions or concerns, contact Technical Support at 1-800-426-6331, option #2, or email Reno.TechSupport@hamiltonmedical.com
Quantity in Commerce 103
Distribution US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = Hamilton Medical AG
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