Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable appli

FDA device recall Z-0296-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Respironics, Inc.

Reason for recall

Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy.

Action taken

Philips Healthcare, began notifying customers via telephone on October 11, 2011. The telephone notification discussed the product, problem and actions to be taken. The customers were instructed to not remove a ventilator from a patient without providing a replacement unit; provide a fax number or email address Philips can use to send the Business Reply Form to complete and return via fax to: 800-733-9962 or email: report.request@philips.com; locate their affected devices (if the device is with a patient, replace it with a non-affected unit-Philips will provide a loaner overnight if needed)-(if the device is in their inventory, quarantine it and return it using the RA number provided in the email/fax that Philips sends them); and If loaner units are needed, they are to call 1-877-387-3311 to arrange return of your affected device and to obtain a loaner unit. If you have any questions or concerns, contact Philips Respironics at 877-387-3311.

Root cause

Process design

Status

Terminated

Product code

CBK

Quantity affected

127

Distribution

Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, GA, ID, IL, KS, MI, MO, NE, NV, NJ, OH, PA, TN, and TX; and countries of: Australia, Austria, Canada, China, Denmark, Germany,

Date initiated

2011-10-11

Date posted

2012-01-11

Date terminated

2012-11-06

Location

Murrysville, PA

Related 510(k) clearances