Z-0296-2012

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

Name: Z-0296-2012 Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and...
Creator: Respironics, Inc.
Published: 2011-10-11
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2011-10-11 / Terminated / root cause: manufacturing process

FDA source

Respironics, Inc. began a recall of Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and... on 2011-10-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0296-2012
Status: Terminated
Initiated: 2011-10-11
Posted: 2012-01-11
Terminated: 2012-11-06
Recalling firm: Respironics, Inc.
Product: 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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: manufacturing process
FDA root cause: Process design
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: [email protected]; 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.
Quantity in commerce: 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, Great Britain, India, Italy, Japan, Korea (Republic of [South] Korea), Netherlands, Philippines, Saudi Arabia, Spain (Espana), and Turkey.
Product codes and lots: 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 code CBK

K083526Class IITrilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group / cleared 2009-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)