Recall Z-1813-2009 ยท CBK Ventilator, Continuous, Facility Use
Respironics California Inc
Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.
| Date | Aug 11, 2009 (initiated Apr 22, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted to the ventilator. When this occurs, the External Battery charger may not transition correctly. Prolonged operation in this condition results in overcharging and |
| Root cause | Device Design |
| Action | Respironics California, Inc. issued an "Urgent - Medical Device Field Correction" notice dated April 22, 2009. Customers were informed of the affected device including corrective actions taken by the firm. A Respironics representative will contact customers to schedule service of the device. Further questions can be addressed by contacting Respironics US Customer Service at 1-800-345-6443. |
| Quantity | 508 |
| Distribution | Worldwide Distribution: United States, Hong Kong, India, Mexico, South Africa and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001208 | ESPIRT Respironics, Inc., May 12, 2000 |
| 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 |
| K051262 | ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 Respironics California, Inc., Jul 8, 2005 |
| K981072 | ESPRIT VENTILATOR Respironics, Inc., Nov 12, 1998 |