Z-0847-2018 Class II Terminated
FDA device recall Z-0847-2018 was initiated by Mindray DS USA, Inc. dba Mindray North America on July 14, 2017 and is designated Class II. 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. The recall status is terminated (terminated April 17, 2019). Affected quantity: 2875 in total.
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.