Ventilator HAMILTON-C6 recall
Ventilator HAMILTON-C6, PN: 160021
Why was Ventilator HAMILTON-C6 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6
- Product
- Ventilator HAMILTON-C6, PN: 160021
- Recalling firm
- Hamilton Medical AG
- Quantity
- 68
- Distribution
- US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
- Recall date
- June 26, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)