Device recall
Z-1242-2018: Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage…
FDA device recall · Class III · Mindray DS USA, Inc. dba Mindray North America
Key facts
| Recall number (Z-number) | Z-1242-2018 |
|---|---|
| Recall event | 79423 |
| Product | Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane… |
| Product code | BZK |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 29, 2018 |
| 510(k) numbers | K062754 |
| FEI number | 2221819 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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