The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to

FDA device recall Z-0354-06 · posted 2006-01-06 · Terminated

Recall details

Recalling firm

Respironics California Inc

Reason for recall

During product testing of the PLV Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient.

Action taken

On November 18, 2005 all affected customers received a personal phone call from Respironics explaining the recall situation in detail. On November 21, 2005, an advisory notice was sent to customers via fax, email, or mail, instructing customers to only use your PLV Continuum Ventilator in the 'Face Foward' orientation. The firm will contact customers with further information shortly to assure that this situation is positively resolved. Customers were instructed to Only use the PL V Continuum Ventilator in the 'Face Forward' orientation. In the event that a customer requires the application of the PLV Continuum Ventilator in the Face Up Orientation, Respironics will provide the customer, at no charge, with a rental PLV-l00, PLV-IO2b or PLV-I02 Ventilator for the customer to use until their PLV Continuum Ventilator is upgraded. If additional information is needed the customer was instructed to contact Respironics'' Customer Service at 800 345-6443.

Root cause

Other

Status

Terminated

Product code

CBK

Quantity affected

268

Distribution

Nationwide, Taiwan, Saudi Arabia, Netherlands, Hong Kong, Canada, Brazil, Australia, and Argentina.

Date initiated

2005-11-18

Date posted

2006-01-06

Date terminated

2008-04-22

Location

Carlsbad, CA

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