Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators ar
FDA device recall Z-0485-2015 · posted 2014-12-01 · Terminated
Recall details
- Recalling firm
- Respironics California Inc
- Reason for recall
- If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.
- Action taken
- Philips Healthcare sent an Urgent - Field Safety Notice to all affected consignees to inform them that Respironics is recalling the Esprit V1000 and Esprit/V200 Conversion ventilators because if the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted. A high urgency audible alarm will sound alerting medical personnel of the loss of power. In the absence of AC power, failure of battery power will cause loss of ventilator support, which may result in hypercarbia or hypoxemia. The potential issue affects ventilators manufactured prior to 12/31/04 due to design of the fan/shroud assembly. Esprit V1000 and Esprit/V200 Conversion Ventilators manufactured after that affected date are not affected. Customers with concerns were instructed to contact a Philips Respironics representative at (800) 722-9377. For questions regarding this recall call 760-918-7300.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 3,943 units total (3,071 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Italy, Korea, Lebanon
- Date initiated
- 2014-10-29
- Date posted
- 2014-12-01
- Date terminated
- 2016-06-07
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 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 |
| 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 |