FDA-Device2016-09-07Class II

A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)

Mindray DS USA, Inc. dba Mindray North America
Hazard

Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.

Sold states
US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada
Affected count
167 units (165 units - US) and (2 units - International)
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2689-2016

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