Recall Check: Philips Ventilators May Stop Working Without Alarm Due to Expired Adhesive

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Philips Respironics V60 and V60 Plus Ventilator Recall Overview:

• Who: Philips Respironics is recalling 1,511 V60 and V60 Plus ventilators.
• Why: Some of the breathing devices have parts that were put together using an expired adhesive that could cause them to stop working suddenly and without alarm.
• Where: The recall is effective in the United States.

Philips Respironics is recalling 1,511 V60 and V60 Plus ventilators because some of the breathing devices have parts that were put together using an expired adhesive that could cause them to stop working without alarm.

In a Class 1 recall notice posted by the U.S. Food and Drug Administration, the company says if the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient.

“This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all,” the notice reads.

Philips Ventilator Failure Could Result In Serious Adverse Health Consequences, Death

If ventilation stops and sounds an alarm, patients could be without support while an alternate ventilator is connected. But, if the ventilator does not sound an alarm, the patient could be deprived of oxygen for an extended time, “which could cause serious adverse health consequences and death,” the notice says.

The ventilators are intended to support patient breathing by providing mechanical ventilation for adults and children who suffer from respiratory failure, chronic respiratory insufficiency or obstructive sleep apnea. The ventilators are used in hospitals or other institutional settings under the direction of health care professionals, the notice says.

Luckily, there have been no reports of injuries, adverse health consequences or death associated with the use of these devices reported to date, Philips Respironics says.

The company sent an Urgent Medical Device Correction Notice to distributors and customers on Jan. 24 with instructions on what to do. Those instructions included connecting the ventilator to a remote alarm system, which could provide a backup warning even if the ventilator’s primary alarm system does not alarm.  

The company also said users should always have immediate access to an alternative means of ventilation.

Customers with questions or concerns about this recall should contact Philips Respironics 24/7 – Customer Care Solutions Center at 1-800-722-9377.

The recall comes the same month as Philips was rebuked by the FDA over poor ventilator recall efforts. On Mar. 10, FDA issued a warning to Philips Respironics after discovering that the company’s “inadequate” efforts to notify the public about recalled respirators had put people in danger. The letter required the company to notify patients and others of its June 14, 2021, recall of certain ventilators, continuous positive airway pressure and bilevel positive airway pressure machines. 

The recall came after the company found there was a “risk of substantial harm to the public health” posed by the degradation of the sound abatement foam used in the products. The breakdown can cause black debris from the foam to be inhaled or swallowed, causing irreversible harm to lung tissues. 

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