Hamilton-c6 recall: Software Issue
HAMILTON-C6, REF: 160021
Why was Hamilton-c6 recalled?
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.
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?
Software Version: 1.2.1, UDI-DI: 07630002808590
- Product
- HAMILTON-C6, REF: 160021
- Recalling firm
- Hamilton Medical AG
- Quantity
- 103
- Distribution
- US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
- Recall date
- May 3, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)