On Tuesday, Royal Philips NV (NYSE:PHG) has issued a correction to the software version used in the Trilogy Evo, Trilogy EV300, Trilogy Evo O2 and Trilogy Evo Universal ventilators to resolve safety issues that may affect the device’s ability to support the patient’s breathing.
The FDA announcement states that this recall is for device correction, not disposal. The FDA has classified this recall as the most serious. This device could cause serious injury or death if continued to use without correction.
Also read: Philips backs annual expectations for higher second-quarter profits despite China’s weakness
In March, Philips Respironics warned customers to update the latest software for the Trilogy Evo continuous ventilators due to a possible power outage. Due to a software issue, these fans may issue a ‘Low Battery’ or ‘Loss of Power’ alarm while sufficient power is still available, resulting in a sudden loss of ventilation while the unit is alarming.
The company is asking users to install a software update to fix issues including false power outage alarms, inaccurate display of the amount of oxygen being delivered to the patient, and inaccuracies in oxygen volume measurement.
Philips now also requires the use of filters in the devices to prevent environmental pollution.
Nine injuries have been reported. One death has been reported. The promotion affects 90,905 units worldwide.
In August 2023, Philips recalled the Respironics Trilogy Evo, Evo O2, EV300 and Evo Universal ventilators after detecting environmental dust and debris in the air path of some devices.
In April, the Dutch medical technology company reached a $1.1 billion settlement in the US over the recall of its Respironics ventilators.
Price promotion: PHG shares are down 1.11% to $32.10 at last check on Thursday.
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This article Philips releases a software solution for some fans to resolve power alarm issues. Oxygen display errors originally appeared on Benzinga.com
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