FDA recall Z-1376-2023

Western/Scott Fetzer Company · Class II · device

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 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

US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.

Key facts

Status
Ongoing
Initiation date
2023-01-03
Report date
2023-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westlake, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1376-2023