Events

Recall of Respironics Trilogy 100, 200 and 202 Ventilators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60099
  • Event Risk Class
    Class 1
  • Event Number
    Z-0296-2012
  • Event Initiated Date
    2011-10-11
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104431
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    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
    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.

Device

Respironics Trilogy 100, 200 and 202 Ventilators
  • Model / Serial
    Serial Numbers: GV111030238, GV111040533, GV111040627, GV111040632, GV111040640, GV111040651, GV111040652, GV111040653, TV011031510, TV011040511, TV011040516, TV011040518, TV011040524, TV011040529, TV011040530, TV011040601, TV011040602, TV011040609, TV011040615, TV109081805, TV109081806, TV109081807, TV111021835, TV111022551, TV0111022832, TV111030422, TV111030441, TV111030445, TV111030453, TV111030774, TV111030790, TV111030853, TV111030932, TV111030947, TV111030976, TV111030978, TV111031001, TV111031011, TV111031037, TV111031045, TV111031057, TV111031064, TV111031067, TV111031113, TV111031403, TV111031413, TV111031420, TV111031462, TV111031554, TV111032252, TV111032254, TV111032306, TV111032316, TV111032562, TV111032809, TV111032811, TV111032812, TV111032822, TV111032827, TV111032829, TV111032830, TV111032832, TV111032833, TV111032901, TV111032905, TV111032906, TV111032909, TV111032912, TV111032913, TV111032914, TV111032920, TV111032923, TV111032924, TV111032925, TV111032926, TV111032929, TV111032934, TV111032935, TV111032938, TV111032939, TV111032940, TV111033001, TV111033004, TV111033005, TV111033006, TV111033009, TV111033010, TV111033016, TV111033018, TV111033019, TV111040110, TV111040113, TV111040117, TV111040404, TV111040405, TV111040411, TV111040415, TV111040416, TV111040418, TV111040419, TV111040420, TV111040423, TV111040424, TV111040428, TV111040432, TV111040438, TV111040703, TV111040729, TV111040735, TV111040803, TV111040808, TV111040830, TV111041118, TV111041304, TV111041306, TV111041435, TV111041436, TV211032405, TV211032409, TV211032412, TV211032413, TV211032414, TV211032415, TV211032419, TV211032420, TV211032430, TV211032431
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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, Great Britain, India, Italy, Japan, Korea (Republic of [South] Korea), Netherlands, Philippines, Saudi Arabia, Spain (Espana), and Turkey.
  • Product Description
    Trilogy 100, 200 and 202 Ventilators || The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Manufacturer Address
    Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668-8517
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA