Recall Z-1376-2023 ยท CAN Regulator, Pressure, Gas Cylinder
Western/Scott Fetzer Company
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)
| Date | Apr 12, 2023 (initiated Jan 3, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| 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 |
| Quantity | 24,287 units |
| Distribution | US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.