Hamilton Medical recalls HAMILTON-C6 ventilators with specific software versions due to potential hypoxia if sensor fail mode occurs after patient reconnection. Affected units have UDI 07630002808590 and software versions v1.1.4 to v1.1.6.
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.
Hamilton Medical is recalling ventilators with specific software versions that may cause hypoxia if a sequence of user actions triggers sensor fail mode. This could lead to insufficient oxygen delivery during critical patient care.
If a user presses O2 enrichment, disconnects the endotracheal tube for suctioning, triggers a sensor error, and reconnects the tube while sensor fail mode is active, the ventilator may not restart ventilation. This can cause the patient to become hypoxic (lack of oxygen).
Healthcare providers using the HAMILTON-C6 ventilator with software versions v1.1.4 to v1.1.6 are most at risk. Patients on ventilators during this sequence may experience hypoxia.
Check for the UDI code 07630002808590 and software versions v1.1.4 through v1.1.6 on the ventilator's label. The product was sold with these specific software versions.
Review the ventilator's software version to confirm it is v1.1.4, v1.1.5, or v1.1.6.
If the ventilator fails to restart after reconnection, check for signs of hypoxia such as shortness of breath or low oxygen levels.
Software versions v1.1.4, v1.1.5, and v1.1.6.
Look for the UDI code 07630002808590 and software versions v1.1.4 through v1.1.6 on the ventilator's label.
Check for hypoxia symptoms like shortness of breath or low oxygen levels. Contact Hamilton Medical for further guidance.
We’ve drafted a message you can send Hamilton Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2020-2024 — Hamilton Medical Hamilton Medical Hello, I own a Hamilton Medical that is covered by recall Z-2020-2024 from Hamilton Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
