Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the ca

FDA device recall Z-1143-2014 · posted 2014-03-06 · Terminated

Recall details

Recalling firm

Phillips Respironics, Inc.

Reason for recall

Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.

Action taken

Philips sent an Urgent - Medical Device Recall letter on February 11, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the Notice with all members of their staff who need to be aware of the contents of the communication. For further information or support concerning the issue, customers were instructed to contact Philips Respironics at 877-387-3311. For questions regarding this recall call 724-733-0200.

Root cause

Component design/selection

Status

Terminated

Product code

CBK

Quantity affected

572

Distribution

Worldwide Distribution - USA (nationwide) and the countries of France, Great Britian, China, India, Italy, Korea, Kuwait, Nehterlands, and Singapore.

Date initiated

2014-02-11

Date posted

2014-03-06

Date terminated

2015-04-17

Location

Murrysville, PA

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