Recall Z-2084-2013— Respironics California Inc

Name: FDA recall Z-2084-2013
Creator: U.S. Food and Drug Administration
Published: 2007-10-29

Class II · Terminated

Class II FDA medical device recall by Respironics California Inc, initiated 2007-10-29, terminated 2013-08-26. It names 5 FDA 510(k) clearances: K041412, K034040, K023350 and 2 more. Product: Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000. Reason: The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable..

Recalling firm: Respironics California Inc
Classification: Class II
Status: Terminated
Initiated: 2007-10-29
Terminated: 2013-08-26
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

5 on FDA's record

K041412 — ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000Respironics California, Inc.·cleared 2004-06-18
K034040 — ESPRIT VENTILATOR, MODEL V1000Respironics, Inc.·cleared 2004-01-21
K023350 — ESPRIT VENTILATOR WITH RESPIRATORY MECHANICSRespironics California, Inc.·cleared 2002-11-06
K001208 — ESPIRTRespironics, Inc.·cleared 2000-05-12
K981072 — ESPRIT VENTILATORRespironics, Inc.·cleared 1998-11-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.