U.S. FDA Identifies Recall of Philips’ Respiratory Devices as Most Serious

By Raghav Mahobe

On April 7, the U.S. Food and Drug Administration (FDA) classified the recall of Philips’ respiratory machines as most serious due to the potential to cause serious injuries or death. In February, Philips Respironics recalled 1,088 devices used by individuals with respiratory conditions to maintain a regular breathing rhythm. The FDA said the recall was due to some devices being assigned incorrect or duplicate serial numbers during initial programming, which could lead to the delivery of therapies using the wrong prescription or factory default settings. Forty-three complaints have been received by the FDA, but no reported injuries or deaths thus far. Philips is contacting patients to coordinate device replacement and return.

Read more on Reuters.