Healthcare technology company Philips has also recalled tens of thousands of respirators from hospitals shortly after the major recall of sleeping and breathing equipment.
According to a report from the US Food and Drug Administration (FDA), such equipment can also have serious health consequences, resulting in injury or even death. The regulator has classified both recalls from Philips in the highest risk category, the so-called Class 1.
The shortcoming with the ventilators concerns a safety system that ensures that the machines sound an alarm when certain maximum oxygen pressure is reached so that the hospital staff can look at the patient. When that happens, the system automatically reduces the oxygen pressure slightly. However, according to a Philips spokesperson, the latter is not desirable in some instances, so Philips has to adjust the devices.
According to the FDA, there are already dozens of known incidents and multiple injuries, but no deaths. Philips says that the ventilators of the types V60 and V60 Plus can continue to be used for the time being, but then the patients will have to be monitored more closely. It is also necessary to react quickly to any alarms.
Based on FDA data, there are more than 23,000 of the affected ventilators in use worldwide, popular in the United States. The Philips spokesperson acknowledges that it can be somewhat confusing that there are multiple recalls of ventilators in a short time. But according to him, users of the devices in question have all been approached.
Philips could not immediately say what the costs for the second recall would be.