Trouble Persists For Philips: Most Serious FDA Recall Label Hits Reworked Respiratory Devices

Koninklijke Philips NV (NYSE PHG) has recalled certain reworked DreamStations respiratory devices because some devices were assigned incorrect or duplicate serial numbers during initial programming.
DreamStation devices help people with breathing conditions keep breathing at a regular rhythm.
This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all.
Also Read: Philips Expects Recall Settlements This Year.
There is no warning or indication to the user that the DreamStation is not working as the doctor intended or prescribed.
Incorrect therapy or therapy failure may lead to several health conditions, such as respiratory failure, heart failure, serious injury, and death.
Philips has received 43 complaints about this issue. There are currently no reported injuries or deaths.
The FDA classified the recall of Philips' respiratory machines as its most serious type, as their use could cause serious injuries or death.
Philips' medical devices maker unit Respironics recalled 1,088 devices in the U.S. on Feb. 10.
The devices were distributed between Dec. 1, 2021, and Oct. 31, 2022.
In December last year, Philips concluded additional test results and assessments for the first-generation DreamStation devices.
Price Action: PHG shares closed at $18.57 on Thursday.