FDA Medical Device Recalls (openFDA)
Respironics California Inc: Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
- Recall number
- Z-2084-2013
- Recalling firm
- Respironics California Inc
- Product
- Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
- Status
- Terminated
- Initiated
- 2007-10-29
- Posted
- 2013-08-26
- Terminated
- 2013-08-26
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Model Number: V1000
- 510(k) numbers
- ["K001208","K023350","K034040","K041412","K981072"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2518422
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28