Esprit Ventilator
FDA device recall Z-1230-04 · posted 2004-07-28 · Terminated
Recall details
- Recalling firm
- Respironics California Inc
- Reason for recall
- Flow sensors would exhibit drift.
- Action taken
- Oxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 907
- Distribution
- Nationwide, Australia, Argentina, Brazil, Canada, Chile, Colombia, Spain, Germany, Hong Kong, India, Italy, Japan, Korea, Mexico, Malaysia, Panama, Philipines, Pakistan, Puerto Rico, Singapore, Thaila
- Date initiated
- 2002-02-20
- Date posted
- 2004-07-28
- Date terminated
- 2004-12-02
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 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 |