Z-0847-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- July 14, 2017
- Termination Date
- April 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2875 in total
Product Description
A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) 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.
Distribution Pattern
Worldwide Distribution - US Nationwide
Code Information
Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.