High FDA (Devices)·Z-2084-2013·Announced 2013-09-04

Respironics V1000 Ventilator Recalled Due to Display Backlight Interruption

Respironics is recalling V1000 ventilators because power interruptions to the display backlight cause the screen to flicker or go dark, making it unreadable.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect renders the display unreadable, which poses a risk of harm to patients using the ventilator, although no injuries have been reported.

Plain-English summary

Respironics California Inc is recalling the Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000. The recall involves 3,255 units, with 2,302 units distributed in the United States. The devices were distributed nationwide in the US and to various countries worldwide.

The recall is due to a defect where power to the Esprit Display's backlight is interrupted. This causes the graphical user interface (GUI) to flicker or go dark, rendering the display unreadable. This issue may prevent users from monitoring the device's status or settings effectively.

Healthcare facilities and users should contact Respironics for further instructions on how to address the defect. The source text does not specify a specific action such as a repair or replacement, nor does it report any injuries or illnesses associated with this defect.

The recalled product

Product: Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Manufacturer: Respironics California Inc
Category: Medical Device — Ventilator
Hazard: display-failure
unreadable-interface

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Model Number: V1000

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Respironics California Inc

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