Digital VIPR Oxygen Delivery Systems Recalled for Gauge Malfunction
Western/Scott Fetzer is recalling 24,287 Digital VIPR oxygen delivery systems for a gauge malfunction that may display incorrect pressure readings. This could allow oxygen tanks to deplete without warning, potentially leaving users without oxygen flow.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a malfunction creating risk of harm to users dependent on continuous oxygen supply. The source explicitly describes a potential hazard—oxygen depletion without warning—but no illnesses or injuries are reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Western/Scott Fetzer Company is recalling 24,287 units of Digital VIPR oxygen delivery systems across multiple model variants. Affected models include Roberts Oxygen Ready to Use Digital VIPR (ROC-9839 head-only; ROC-9840 with E-size cylinder) and Western Oxytote DTE Digital VIPR (MNDR-600 head-only; MNDS-602 with D-size cylinder; MNDS-603 with E-size cylinder). These units were distributed from May 29, 2020 through December 7, 2022.
The digital gauge on these devices can malfunction and display tank pressure readings that are higher than the actual pressure in the tank. This inaccurate reading may cause the oxygen tank to run out of oxygen during use without triggering audible alarms, potentially resulting in an out-of-oxygen event and loss of oxygen flow.
The affected devices have been distributed in Colorado, Connecticut, Idaho, Maryland, Montana, Tennessee, and Washington.
The recalled product
- 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…
- Manufacturer
- Western/Scott Fetzer Company
- Affected units
- 24,287
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- ROC-9839
- Western Oxytote DTE Digital VIPR (head only) o UDI-DI: B929MNDR6000 MNDS-602
Distribution
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