Z-1376-2023Class II

Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to...

Name: Z-1376-2023 Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to...
Creator: Western/Scott Fetzer Company
Published: 2023-01-03
License: https://open.fda.gov/license/

Western Enterprises, Inc. / initiated 2023-01-03 / Open, Classified

FDA source

Western/Scott Fetzer Company began a 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 E-size cylinder)... on 2023-01-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1376-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-03
Posted: 2023-04-12
Recalling firm: Western Enterprises, Inc.
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)
Product code: CAN Regulator, Pressure, Gas 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.
FDA root cause: Under Investigation by firm
Action: On January 3, 2023, the firm issued a Safety Alert to customers. Customers were provided with updated operating instructions. Customers instructed to take the following immediate actions: 1. Implement updated filling and venting instructions which include steps for the filler to verify proper gauge pressure after vent down and after fill/re-fill. 2. Implement an additional verification of gauge pressure upon delivery at the healthcare facility. 3. Take care to minimize any impact to the cylinder during use, transportation, or processing during fill/re-fill. The firm continues to evaluate the gauge error issue and will implement additional corrective actions as appropriate.
Quantity in commerce: 24,287 units
Distribution: US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1376-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1376-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12

Product code CAN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)