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U.S. Department of Health and Human Services

Class 2 Device Recall Digital VIPR

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  Class 2 Device Recall Digital VIPR see related information
Date Initiated by Firm January 03, 2023
Date Posted April 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-1376-2023
Recall Event ID 91561
Product Classification Regulator, pressure, gas cylinder - Product Code CAN
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)
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.
Recalling Firm/
Manufacturer		 Western/Scott Fetzer Company
875 Bassett Rd
Westlake OH 44145-1142
For Additional Information Contact Christine White
440-871-2160
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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