Medical Device Network

FDA identifies Hamilton Medical ventilator recall as Class I

Following reports of software issues Hamilton Medical voluntarily recalled four models of its ventilators which the FDA has labelled as a Class I recall.

Ventilator manufacturer Hamilton Medical has launched a voluntary recall of four of its ventilators following reports of software troubles that cause the device to stop working without warning.

The products in question assist patients who need full and partial breathing assistance and are used for the transportation of patients.

The US Food and Drug Administration (FDA) has categorised it as a Class I recall meaning there is a possibility for serious injury or death from using the devices.

The software problems inadvertently cause the affected ventilators to switch to Ambient State mode if used for more than 91 days without a restart. Health care professionals will then need to step in ensuring the air supply is not restricted with a manual resuscitating device.

The ventilators that come under this recall include HAMILTON-C1, C2, C3 and T1 models which were distributed between December 10th, 2010, and May 1st, 2023.

So far out of the 80 complaints received there’ve been no reports of injuries our death and a total of 21,429 devices have been recalled in the US.

Hamilton Medical issued letters to those affected by the software problems on June 15th advising them to immediately replace ventilators and switch off the device to get out of the Ambient State mode.

During the Covid-19 pandemic the demand for ventilators skyrocketed. According to a report from GlobalData, the ventilators market was worth nearly $1.1 Billion in 2019 and is expected to reach $1.5 Billion by 2028, led by the intensive care unit (ICU) ventilators segment.