FDA-Device2012-12-26Class II

BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

Del Mar Reynolds Medical, Ltd.
Hazard

The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.

Sold states
Worldwide Distribution--USA (nationwide) including states of North Carolina and Oklahoma and the countries of Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republic, Ecuador, Egypt, Finland, Ghana, Great Britian, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates , Uruguay, Venezuela, and Vietnam.
Affected count
3 in US and 3121 Outside US
Manufactured in
1-2 Harforde Ct., Foxholes, Business Park, Hertford, United Kingdom
Products
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2013

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