Recall Z-0296-2012 ยท CBK Ventilator, Continuous, Facility Use
Respironics, Inc.
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.
| Date | Jan 11, 2012 (initiated Oct 11, 2011) |
| Status | Terminated |
| 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. |
| 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: 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)-(i |
| Quantity | 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, Sa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083526 | TRILOGY 100 VENTILATOR Respironics Inc., Sleep & Home Respiratory Group, Mar 13, 2009 |