Here are six recent warnings the FDA has issued since Jan. 1:
Philips imaging machine might fall on patients
Philips told users of its BrightView imaging machines the detector might fall because of a component failure. One incident and zero injuries or deaths have been reported.
The BrightView machines take images of biological activity in the human body. If the detector is above the center of gravity, clinical imaging will be interrupted. If it's below the center of gravity, the detector could fall "in an uncontrolled manner and contact the patient," the FDA said.
50K syringe pumps flagged for delay risk
Smiths Medical notified customers of 50,743 syringe pumps of a software issue that can cause serious injury or death, according to the FDA.
An earlier software version of the product, the Medfusion Model 4000 Syringe Infusion Pump, might disrupt therapy administration and affect the alarm system, pump, control screen and other parts. As of Feb. 14, one injury and zero deaths have been reported.
2K breathing kits used in hospitals recalled
Percussionaire is recalling 2,145 breathing circuit kits in a Class I recall, the most serious type, because of a product defect.
The High Frequency Transport Phasitron Breathing Circuit Kits are used in hospitals and emergency care sites. Two parts in the device might be incorrectly angled and pressed together, forcing the positive end expiratory pressure valve to be stuck in the closed position, according to the FDA. Three complaints, one injury and zero deaths have been reported.
Philips halts sales of sleep apnea devices under FDA deal
Philips will stop selling sleep apnea devices in the U.S. under a consent decree agreement with the FDA.
Under the agreement, Philips will not sell new sleep apnea machines and ventilators through its Respironics division but will continue to serve existing customers with accessories and replacement parts.
After millions of machines were recalled in 2021, more than 500 deaths have been reported. Philips told Becker's it reviews all allegations.
Hospitals worry over helium supply
As the U.S. government works to sell the Federal Helium Reserve, which supplies around 30% of the nation's helium, hospitals are growing concerned the transaction could worsen an ongoing shortage.
MRI machines typically need around 2,000 liters of helium to operate, but supply of the element has been thinning. Three of five helium suppliers in the U.S. are reserving product for MRI machines to prevent care coordination issues.
20M CPAP masks might interfere with medical devices: FDA
There is a risk of serious injury or death related to more than 20 million CPAP masks made by ResMed, the FDA said.
The AirFit and AirTouch continuous positive airway pressure masks have magnets on the headgear to make the device comfortable. The label advises keeping the magnets at least 2 inches away from the mask, but the label is incomplete, according to the FDA.
ResMed has received six reports of injuries and no reports of death related to disrupted medical implants and devices.