Mar

2016

Cl II Philips Trilogy

Company: Philips Respironics.
Date of Enforcement Report 3/46/2016
Class lI:

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.. Recall Number Z-1065-2016

REASON
Software issue.

RECALLING FIRM/MANUFACTURER
Philips Respironics, Monroeville, PA on 3/7/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
104,508 units

DISTRIBUTION
Worldwide

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Philips Trilogy

Amy Sellers

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