Z-1376-2023 Class II Ongoing
FDA device recall Z-1376-2023 was initiated by Western/Scott Fetzer Company on January 3, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 24,287 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- January 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,287 units
Product Description
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 for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.
Code Information
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.