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Terminated

Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.

FDA Recall Z-1813-2009 · Posted 2009-08-11

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2009-04-22
Date Terminated2012-07-13
Product Quantity508

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: United States, Hong Kong, India, Mexico, South Africa and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051262ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000Respironics California, Inc. · 2005-07-08K041412ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000Respironics California, Inc. · 2004-06-18K034040ESPRIT VENTILATOR, MODEL V1000Respironics, Inc. · 2004-01-21K001208ESPIRTRespironics, Inc. · 2000-05-12K981072ESPRIT VENTILATORRespironics, Inc. · 1998-11-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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