Philips Respironics Initiates Recall of Trilogy Ventilator

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Philips Respironics Initiates Recall of Trilogy Ventilator

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Respironics, Inc. has announced a worldwide recall of approximately 600 Philips Respironics Trilogy Ventilators. The voluntary recall is meant to address a potentially defective component on the Trilogy Ventilator power management board, which could affect the function of the device.

If left unaddressed, it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in serious adverse health consequences or death, according to the release.

The Philips Respironics Trilogy Ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys.

Philips Respironics discovered during production testing that the Trilogy ventilators contain a potentially defective ferrite component on the power management board of the device. This recall affects 600 Trilogy Ventilator devices shipped between December 31, 2013, and January 30, 2014.

Recall Instructions

Philips Respironics is instructing customers to remove affected devices from service and to return them to Philips for replacement. All distributors, providers, and customers with potentially affected Trilogy devices will have their units replaced.

Philips Respironics has notified all United States and international distributors, providers, and customers that may have devices subject to this recall, and has provided affected device serial numbers for identification. Serial numbers of affected devices are located on the back of the device, as indicated in the accompanying product image.

Countries where affected devices have been shipped include the United States, France, United Kingdom, Hong Kong, India, Italy, Korea, Kuwait, Netherlands, and Singapore.

Further Information or Support

Customers who have questions about the recall or require further information or support concerning this issue, may contact their local Philips Respironics representative via the Customer Care Center phone number: 1-800-345-6443, which is active 24/7.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Source: FDA Safety Recalls

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