Recall Z-0846-2018— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-0846-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-14

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2017-07-14, terminated 2019-04-17. It names one FDA 510(k) clearance: K123211. 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: 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: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2017-07-14
Terminated: 2019-04-17
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123211 — A5 ANESTHESIA DELIVERY SYSTEMDatascope Corp., Patient Monitoring Division·cleared 2013-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.