Trilogy 100…

Date

March 16, 2016

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Philips Respironics

Product

Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

Reason

Software Issue

Distribution pattern

Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.

Quantity

104,508 units

Codes and lots

11 digit S/N begginning with GV or TV; also TGY1D01463

Recall started

Jan. 18, 2016

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Software design

What the company told customers

Philips Respironics has determined that affected devices may continue to be used in accordance with the device Instructions for Use and the Field Safety Notification that is being issued to customers. Philips Respironics will be providing a software update for affected devices free of charge. Customers will be notified by mail when the software update is available for download. For further questions please call ( 724 ) 387-7500.

Recall number

Z-1065-2016

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1065-2016. The agency record governs; check it and the company before acting.