Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
FDA device recall Z-2084-2013 · posted 2013-08-26 · Terminated
Recall details
- Recalling firm
- Respironics California Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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,
- Date initiated
- 2007-10-29
- Date posted
- 2013-08-26
- Date terminated
- 2013-08-26
- Location
- Carlsbad, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 (K041412) | Respironics California, Inc. | 2004-06-18 |
| ESPRIT VENTILATOR, MODEL V1000 (K034040) | Respironics, Inc. | 2004-01-21 |
| ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS (K023350) | Respironics California, Inc. | 2002-11-06 |
| ESPIRT (K001208) | Respironics, Inc. | 2000-05-12 |
| ESPRIT VENTILATOR (K981072) | Respironics, Inc. | 1998-11-12 |