Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2018 - (Recall #: Z-0846-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 14, 2017

Date Posted: March 14, 2018

Recall Number: Z-0846-2018

Event ID: 79133

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.

Status: Terminated

Product Quantity: 2875 in total

Code Information:

Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.

Distribution Pattern:

Worldwide Distribution - US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated