Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator us

FDA device recall Z-1606-2009 · posted 2009-07-07 · Terminated

Recall details

Recalling firm

Respironics California Inc

Reason for recall

Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cau

Action taken

Respironics California, Inc. issued an "Attention - Medical Device Field Correction" letter addressed to the Customer/Distributor dated September 22, 2008. The letter informed consignees of the affected device and instructions for removal, device replacement and return of the Business Response form by fax to 1-760-918-0169. Further question may be addressed to Respironics US Customer Service at 1-9800-345-6443 extension 5 or Respironics International Customer Service at 1-724-387-4000.

Root cause

Component design/selection

Status

Terminated

Product code

MNS

Quantity affected

2,270 Power Cords

Distribution

Worldwide to Argentina, Australia, Belgium, Brazil, Cambodia, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Libya, Malaysia, Mex

Date initiated

2008-09-22

Date posted

2009-07-07

Date terminated

2010-07-06

Location

Carlsbad, CA

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