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.
- Recall Initiated
- July 14, 2017
- Terminated
- April 17, 2019
- Recall Number
- Z-0846-2018
- Quantity
- 2875 in total
- Firm Location
- Mahwah, NJ
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
Lot / Code Info
Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
Root Cause
Device Design
Action Taken
Mindray sent an Urgent Medical Device Correction letter dated June 9, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Corrective Action: In order to eliminate any potential for the EEPROM issue to manifest, Mindray is offering two options for upgrading affected systems in your facility: Option 1: You may perform the software upgrade if your facility has Biomedical Engineering or other staff that have been trained by Mindray to perform maintenance operations on the ASeries. Please contact Mindray's Technical Support team who will assist with providing the software and instructions for performing the software upgrade. The Technical Support can be reached at (877) 913-9663 (Option 1). Option 2: A Mindray Service Representative will upgrade the affected systems in your facility at no charge. Please contact your Mindray Service Representative to arrange for this upgrade at (877) 913-9663 (Option 8). Both the Technical Support and Service teams may be reached Monday through Friday, 8:30am - 5:30pm, ET.