Recall Z-1896-2010 ยท CBK Ventilator, Continuous, Facility Use
Respironics, Inc.
Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
| Date | Jun 24, 2010 (initiated Jun 10, 2010) |
| Status | Terminated |
| Reason | It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event. |
| Root cause | Nonconforming Material/Component |
| Action | Philips Respironics has contacted all of its consignees by phone and instructed them to remove the potentially affected external battery packs from their inventory and any that may be on their patients/end users. These consignees have been instructed to quarantine batteries they have removed away from flammable materials. Product return/replacement instructions were provided. For further information, contact Philips Respironics at 1-877-387-3311. |
| Quantity | 23 units |
| Distribution | Worldwide Distribution -- United States (MT, IL, IA, NY, NC, TX, CA and FL), France, South Korea and Turkey. |
| 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 |