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.
Z-0846-2018
Product summary
- Event
- Event 79133
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2875 in total
- Official record key
device-enforcement:Z-0846-2018
Official wording
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.
Code information: Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
Distribution pattern: Worldwide Distribution - US Nationwide
Derived failure modes
-
Device software or design
software issue