Recall Z-0903-04 ยท CBK Ventilator, Continuous, Facility Use
Respironics California Inc
Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
| Date | Jul 20, 2004 (initiated Jun 1, 2001) |
| Status | Terminated |
| Reason | Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue. |
| Root cause | Other |
| Action | Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01. |
| Quantity | 749 |
| Distribution | Nationwide, Argentina, Brazil, Canada, China, Chile, Egypt, India, Italy, Japan, Korea, Mexico, Pakistan, Panama, Philipines, Puerto Rico, Singapore, Spain, Thailand, Turkey, Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981072 | ESPRIT VENTILATOR Respironics, Inc., Nov 12, 1998 |