Device recall
Z-0846-2018: A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3)…
FDA device recall · Class II · Mindray DS USA, Inc. dba Mindray North America
Key facts
| Recall number (Z-number) | Z-0846-2018 |
|---|---|
| Recall event | 79133 |
| 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… |
| Product code | BSZ |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2019 |
| 510(k) numbers | K123211 |
| FEI number | 2221819 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database