Recall Z-2084-2013 ยท CBK Ventilator, Continuous, Facility Use
Respironics California Inc
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
| Date | Aug 26, 2013 (initiated Oct 29, 2007) |
| Status | Terminated |
| 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, Spai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001208 | ESPIRT Respironics, Inc., May 12, 2000 |
| K023350 | ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS Respironics California, Inc., Nov 6, 2002 |
| K034040 | ESPRIT VENTILATOR, MODEL V1000 Respironics, Inc., Jan 21, 2004 |
| K041412 | ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 Respironics California, Inc., Jun 18, 2004 |
| K981072 | ESPRIT VENTILATOR Respironics, Inc., Nov 12, 1998 |