FDA Deems Hamilton Ventilator Recall Class I for Software Issue Causing Device to Stop
The FDA has deemed Hamilton Ventilators’ recall of its C1, C2, C3, T1 ventilators as class I, as the company has received reports of software issues that may cause the ventilators to stop without notice, with the potential for serious injury or death.
The ventilator may switch to “Ambient State,” cease functioning and issue an alarm if used for more than 91 days without a restart.
The firm issued the recall for the 21,429 potentially affected devices on June 15, sending a notice to all customers advising them to provide alternative ventilation immediately and service the ventilator once patient safety is ensured. The ventilator may be returned to use after the service is completed.
There have been 80 reported complaints, but no injuries or deaths related to this recall.
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