FDA Device recall Z-1376-2023
Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with…
- FDA Device
- Class II
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class II recall of Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with… by Western Scott Fetzer, citing gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1376-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-03 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Western Scott Fetzer |
| Distribution | US |
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, Western Oxytote DTE Digital VIPR System (with E-size cylinder)
Reason
Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without audible alarms, potentially leading to an out of oxygen event and no flow.
Identifiers
| code_info | ROC-9839, Roberts Oxygen Ready to Use Digital VIPR (head only) o UDI-DI: B929ROC98390 ROC-9840, Roberts Oxygen Ready t…ROC-9839, Roberts Oxygen Ready to Use Digital VIPR (head only) o UDI-DI: B929ROC98390 ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) o UDI-DI: B929ROC98400 MNDR-600, Western Oxytote DTE Digital VIPR (head only) o UDI-DI: B929MNDR6000 MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) o UDI-DI: B929MNDS6020 MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder) o UDI-DI: B929MNDS6030 All units distributed from 05/29/2020 to 12/7/2022. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1376-2023%22
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