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Mindray DS USA, Inc. dba Mindray North America recalls A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage:
Recalled March 14, 2018 · FDA recall Z-0846-2018 · Mindray DS USA, Inc.
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. · FDA Class II
Units
2875 in total
Sold at
Worldwide Distribution - US Nationwide
Description
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.
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.
Manufacturer(s)
Mindray DS USA, Inc. dba Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →