FDA-Device2018-03-14Class II
A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.
Mindray DS USA, Inc. dba Mindray North America
Hazard
A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
Sold states
Worldwide Distribution - US Nationwide
Affected count
2875 in total
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0846-2018Don't want to check this manually?
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