Z-1896-2010

Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville...

Name: Z-1896-2010 Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville...
Creator: Respironics, Inc.
Published: 2010-06-10
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2010-06-10 / Terminated / root cause: manufacturing process

FDA source

Respironics, Inc. began a recall of Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent... on 2010-06-10. The reason FDA records is "It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1896-2010
Status: Terminated
Initiated: 2010-06-10
Posted: 2010-06-24
Terminated: 2010-11-18
Recalling firm: Respironics, Inc.
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.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.
Root cause tag: manufacturing process
FDA 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 in commerce: 23 units
Distribution: Worldwide Distribution -- United States (MT, IL, IA, NY, NC, TX, CA and FL), France, South Korea and Turkey.
Product codes and lots: Serial Numbers: TV110051146, TV110051147, TV110051347, TV110051335, TV110050717, TV110052245, TV110051033, TV110051130, TV110050733, TV110051133, TV110051336, TV110051144, TV110051241, TV110051236, TV110051344, TV110051333, TV110051338, TV110051340, TV110051352, TV110051348

Product code CBK

K083526Class IITrilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group / cleared 2009-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)