A-Series A7 Anesthesia Delivery System — Class II medical device recall Z-0847-2018
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2018-03-14, distributed nationwide. A software issue may result in the previous settings being applied instead of the default settings or the unit
| Recall number | Z-0847-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2017-07-14 |
| Classified | 2018-03-02 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,875 in |
| Reason classes | packaging, software |
| Model numbers | 0632F-PA0000X |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0847-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.