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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 Recall
Trilogy 100 Ventilator
see related information
Date Posted June 24, 2010
Recall Status1 Terminated on November 18, 2010
Recall Number Z-1896-2010
Recall Event ID 55939
Premarket Notification
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, Pennsylvania 15668-8517
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
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