FDA Device recall Z-0846-2018
A-Series A3/A5 Anesthesia Delivery System
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of A-Series A3/A5 Anesthesia Delivery System by Mindray Ds Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0846-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-14 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
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.
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.
Identifiers
| code_info | Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0846-2018%22
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