FDA issues two sets of ventilator recalls

Key takeaways:

• The FDA designated recalls of ventilation products from Hamilton Medical and Philips Respironics.
• No injuries or deaths have been reported with use of either device.

This week, the FDA issued two class I recalls, the most serious kind, for ventilators from two companies.

The first recall is for three different ventilators made by Hamilton Medical: Hamilton-C1, Hamilton-T1 and Hamilton-MR1.

According to the FDA alert, the devices were recalled because of the possibility of electrolyte fluid leaking from the capacitators, which could lead to the ventilator’s control board short circuiting and causing a switch to “Ambient State.”

Receiving the “Ambient State” message on the ventilator may require clinicians to provide air supply with a manual resuscitating device or place the patient on a different ventilator, the FDA stated in the alert.

The recall is for 1,468 devices in the United States, and the affected units were distributed from July 28, 2020, to Aug. 8, 2020.

The FDA noted that there are currently no incidents, injuries or deaths linked to these devices.

Hamilton Medical sent users an Urgent Medical Device Correction letter on July 26, 2023, alerting them to seek service for the ventilator if it shows the “Ambient State” screen. The FDA wrote in the alert that the device can be used again if it passes the service software tests.

The second recall is for the Philips Respironics V60 Ventilators and V60 Plus Ventilators that assist pediatric and adult patients with breathing.

The devices were recalled because the power management printed circuit board assemblies fail to meet ventilator standards as they were distributed by a third-party warehouse.

The FDA noted that patients on these ventilators who do receive direct monitoring may be at a higher risk.

Power failure, loss of ventilator function and death are potential adverse outcomes that may occur due to this issue, according to the alert.

This recall is for eight devices in the United States, and the affected units were only distributed on May 6, 2023.

There are currently no injuries or deaths related to this issue, Philips Respironics reported to the FDA.

Philips Respironics sent users an Urgent Medical Device Correction letter in August 2023, advising them to stop using the ventilator and to quarantine it until a representative from the company can tell them how to remove/replace the power management printed circuit board assemblies.

Reference:

• Philips Respironics recalls V60 and V60 Plus Ventilators due to power management printed circuit board assemblies (PM PCBAs) not meeting ventilator standards. https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-v60-and-v60-plus-ventilators-due-power-management-printed-circuit-board. Published Oct. 20, 2023. Accessed Oct. 20, 2023.