FDAClass IISeptember 4, 2013

Continuous Ventilator/Continuous Ventilator with recall

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

Why was Continuous Ventilator/Continuous Ventilator with recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: V1000

Product
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Recalling firm
Respironics California Inc
Quantity
3,255 units (2302 units in US)
Distribution
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.
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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