Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. P
FDA device recall Z-1896-2010 · posted 2010-06-24 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 23 units
- Distribution
- Worldwide Distribution -- United States (MT, IL, IA, NY, NC, TX, CA and FL), France, South Korea and Turkey.
- Date initiated
- 2010-06-10
- Date posted
- 2010-06-24
- Date terminated
- 2010-11-18
- Location
- Murrysville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY 100 VENTILATOR (K083526) | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-13 |