Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.
FDA device recall Z-1813-2009 · posted 2009-08-11 · Terminated
Recall details
- Recalling firm
- Respironics California Inc
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 508
- Distribution
- Worldwide Distribution: United States, Hong Kong, India, Mexico, South Africa and Vietnam.
- Date initiated
- 2009-04-22
- Date posted
- 2009-08-11
- Date terminated
- 2012-07-13
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 (K051262) | Respironics California, Inc. | 2005-07-08 |
| 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 |
| ESPIRT (K001208) | Respironics, Inc. | 2000-05-12 |
| ESPRIT VENTILATOR (K981072) | Respironics, Inc. | 1998-11-12 |