FDAJuly 14, 2017device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

mindray ds usa inc dba mindray north americamindraymindray ds

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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