Z-2084-2013Class II

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

Name: Z-2084-2013 Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Creator: Respironics California Inc
Published: 2007-10-29
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2007-10-29 / Terminated / root cause: design

FDA source

Respironics California Inc began a recall of Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000 on 2007-10-29. FDA classified it as Class II and gives the reason as "The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2084-2013
Classification: Class II
Status: Terminated
Initiated: 2007-10-29
Posted: 2013-08-26
Terminated: 2013-08-26
Recalling firm: Respironics, Inc.
Product: Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.
Root cause tag: design
FDA root cause: Device Design
Action: A Medical Device Field Correction letter dated 10/26/2007 was sent to all customers who received the Esprit Ventilator. The recall letter informed the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact Respironics' Customer Service Dept. at (800) 345-6443, select Option#5, then select Option #4.
Quantity in commerce: 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.
Product codes and lots: Model Number: V1000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2084-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2084-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code CBK

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)