Device recall
Z-1376-2023: Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only)…
FDA device recall · Class II · Western/Scott Fetzer Company
Key facts
| Recall number (Z-number) | Z-1376-2023 |
|---|---|
| Recall event | 91561 |
| Product | Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603… |
| Product code | CAN |
| Recalling firm | Western/Scott Fetzer Company |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1526809 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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