Company:Mindray DS USA, Inc. dba Mindray North America
Date of Enforcement Report 3/14/2018
Class lI:
PRODUCT
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. Recall Number Z-0846-2018
A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product
Recall Number Z-0847-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc. dba Mindray North America, Mahwah NJ on 7/14/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2875
DISTRIBUTION
Nationwide
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