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Trilogy 100 Ventilator, Model/Catalog Number 1054260… recallZ-1896-2010 · Respironics, Inc. · initiated Jun 10, 2010

Terminated All recalls posted in June 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Respironics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1896-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 10, 2010
Posted by the FDA
Jun 24, 2010
Recalling firm
Respironics, Inc.
Quantity
23 units
Product code
CBK
FDA submissions
K083526
Distribution
Worldwide Distribution -- United States (MT, IL, IA, NY, NC, TX, CA and FL), France, South Korea and Turkey.

Product description

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 (models, lots, serial numbers)

Serial Numbers: TV110051146, TV110051147, TV110051347, TV110051335, TV110050717, TV110052245, TV110051033, TV110051130, TV110050733, TV110051133, TV110051336, TV110051144, TV110051241, TV110051236, TV110051344, TV110051333, TV110051338, TV110051340, TV110051352, TV110051348

Other devices under the same FDA submission

23 devices cleared under K083526 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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