Nicko displays the device, a Philips DreamStation, to the camera, noting that it has “now been recalled.” He claims this is because the sound-abating foam inside breaks down, “and then it travels into ...
Philips is recalling the software associated with its mobile cardiac outpatient telemetry devices after 109 patient injuries and two patient deaths, a Jan. 13 FDA recall notice said. The software ...
The issues have largely surrounded the brand's popular DreamStation CPAP ... the consequences of the Respironics recall," said Roy Jakobs, CEO of Royal Philips, in a statement.
The FDA is elevating a recall ... a list of potentially affected patients on a secure website. There, clinicians can request for their ECG reports to be reprocessed and reanalyzed. Philips said ...
The Class I recall, the FDA’s severest classification, is a correction and does not require removing devices from where they are used or sold. Philips started the recall on Nov. 20, 2024 ...