FDA recall Z-0846-2018

Mindray DS USA, Inc. dba Mindray North America · Class II · device

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.

Reason for recall

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.

Distribution

Worldwide Distribution - US Nationwide

Key facts

Status
Terminated
Initiation date
2017-07-14
Report date
2018-03-14
Termination date
2019-04-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0846-2018