Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
FDA device recall Z-0903-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Respironics California Inc
- Reason for recall
- Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
- Action taken
- Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 749
- Distribution
- Nationwide, Argentina, Brazil, Canada, China, Chile, Egypt, India, Italy, Japan, Korea, Mexico, Pakistan, Panama, Philipines, Puerto Rico, Singapore, Spain, Thailand, Turkey, Vietnam.
- Date initiated
- 2001-06-01
- Date posted
- 2004-07-20
- Date terminated
- 2004-05-12
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESPRIT VENTILATOR (K981072) | Respironics, Inc. | 1998-11-12 |