Z-1606-2009

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

Name: Z-1606-2009 Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support...
Creator: Respironics California Inc
Published: 2008-09-22
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2008-09-22 / Terminated / root cause: design

FDA source

Respironics California Inc began a recall of Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients... on 2008-09-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1606-2009
Status: Terminated
Initiated: 2008-09-22
Posted: 2009-07-07
Terminated: 2010-07-06
Recalling firm: Respironics, Inc.
Product: Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.
Product code: MNS Ventilator, Continuous, Non-Life-Supporting
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
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 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, Mexico, Netherlands, New Zealand, Norway, Oman, Portugal, Puerto Rico, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States and Venezuela.
Product codes and lots: Model Numbers: 8-400169-00, 7-400076-00, 8-400179-00, 8-400258-00, 8-400259-00, 8-400260-00, 8-400261-00 and 8-400216-00.

Product code MNS

K053168Class IIBIPAP FocusRespironics (Ireland) Limited / cleared 2006-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)