Respironics California, Inc., a medical supply company, is undergoing a Class 1 Recall for defective ventilators, the company reports.
The ventilators, under the model number V60, have been experiencing onboard software issues that potentially cause the machines to shut down, presenting a serious and potentially fatal health risk; because ventilators are intended to help patients breath when they are unable to do so, the interruption of the machine’s function could lead to patient suffocation.
The company has notified all of its customers, providers and distributors of the recall, which the FDA classified as “Class 1.” The FDA ranks recalls according to how serious a risk they pose to health and mortality; Class 1 is the highest, signifying that the use of the product “will cause serious adverse health consequences or death.”
Recalls of dangerous and potentially fatal products happen frequently, and it is critical that companies and corporations act swiftly in ensuring that hazardous products are taken off the shelves and out of public use as soon as a problem is identified. As an invaluable watchdog for these types of malfunctions, the FDA maintains a program known as MedWatch that provides resources and information regarding recalls and medical equipment problems.