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Recall Observatory FDA recall evidence

Device product

Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000

Z-2084-2013

October 29, 2007

Class II

Product summary

Firm
Respironics California Inc
Event
Event 48997
Status
Terminated
Classification
Class II
Quantity
3,255 units (2302 units in US)
Official record key
device-enforcement:Z-2084-2013

Official wording

Reason: The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.

Code information: Model Number: V1000

Distribution pattern: USA Nationwide and Worldwide to Algeria, Argentina, Australia, Bangladesh, Brazil, Cambodia, Canada, Chile, Colombia, Ecuador, Egypt, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Libya, Malaysia, Mexico, Pakistan, Peru, Philippines, Puerto Rico, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.