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U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy 100 Ventilator

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  Class 2 Device Recall Trilogy 100 Ventilator see related information
Date Initiated by Firm June 10, 2010
Date Posted June 24, 2010
Recall Status1 Terminated 3 on November 18, 2010
Recall Number Z-1896-2010
Recall Event ID 55939
510(K)Number K083526  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product 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.
Code Information Serial Numbers: TV110051146, TV110051147, TV110051347, TV110051335, TV110050717, TV110052245, TV110051033, TV110051130, TV110050733, TV110051133, TV110051336, TV110051144, TV110051241, TV110051236, TV110051344, TV110051333, TV110051338, TV110051340, TV110051352, TV110051348 
Recalling Firm/
Manufacturer		 Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact
724-733-0200
Manufacturer Reason
for Recall		 It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.
FDA Determined
Cause 2		 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 in Commerce 23 units
Distribution Worldwide Distribution -- United States (MT, IL, IA, NY, NC, TX, CA and FL), France, South Korea and Turkey.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
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