Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Ventilator HAMILTONC6

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Ventilator HAMILTONC6see related information
Date Initiated by FirmMay 15, 2024
Date PostedJune 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2020-2024
Recall Event ID 94671
510(K)NumberK201658 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductVentilator HAMILTON-C6, PN: 160021
Code Information UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6
Recalling Firm/
Manufacturer		 Hamilton Medical AG
Via Crusch 8
Bonaduz Switzerland
For Additional Information Contact
41816606010
Manufacturer Reason
for Recall		Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
FDA Determined
Cause 2		Packaging change control
ActionOn 5/24/24, correction notices were emailed to customers and distributors and they were asked to do the following: If ventilation is not re-initiated due to this issue, there are 4 ways to reinitiate ventilation: 1) Select and confirm a control setting (even without a change of the value), or 2) Select and confirm a new ventilation mode, or 3)Switch the ventilator to standby mode and restart ventilation from standby mode, or 4) Switch the ventilator off and switch it on again If the user is not able to manually re-initiate ventilation in due time as per one of the 4 ways described above, they might decide to ventilate the patient by alternative means. - Read and sign the confirmation sheet, which can be returned to bret.everett@hamiltonmedical.com - Ensure that your medical staff is aware of the notice content - Attach this letter to each affected device's operator's manual in order to ensure quick access. - The newest available software version 1.2.3 contains the required fix and shall be installed without undue delay. Your local distribution partner will support you with updating your affected devices with high priority. Questions, contact techsupport@hamilton-medical.com
Quantity in Commerce68
DistributionUS Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
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 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) Database510(K)s with Product Code = CBK
-
-