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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 Ventilatorsee related information
Date Initiated by FirmJune 10, 2010
Date PostedJune 24, 2010
Recall Status1 Terminated 3 on November 18, 2010
Recall NumberZ-1896-2010
Recall Event ID 55939
510(K)NumberK083526 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductTrilogy 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
ActionPhilips 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 Commerce23 units
DistributionWorldwide Distribution -- United States (MT, IL, IA, NY, NC, TX, CA and FL), France, South Korea and Turkey.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CBK
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