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Terminated

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

FDA Recall Z-2084-2013 · Posted 2013-08-26

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2007-10-29
Date Terminated2013-08-26
Product Quantity3,255 units (2302 units in US)

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.

Firm 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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041412ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000Respironics California, Inc. · 2004-06-18K034040ESPRIT VENTILATOR, MODEL V1000Respironics, Inc. · 2004-01-21K023350ESPRIT VENTILATOR WITH RESPIRATORY MECHANICSRespironics California, Inc. · 2002-11-06K001208ESPIRTRespironics, Inc. · 2000-05-12K981072ESPRIT VENTILATORRespironics, Inc. · 1998-11-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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