Recall Z-0846-2018 ยท BSZ Gas-Machine, Anesthesia
Mindray DS USA, Inc. dba Mindray North America
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
| Date | Jul 14, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 2875 in total |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123211 | A5 ANESTHESIA DELIVERY SYSTEM Datascope Corp., Patient Monitoring Division, Feb 14, 2013 |