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

FDA device recall Z-1376-2023 · posted 2023-04-12 · Open, Classified

Recall details

Recalling firm

Western/Scott Fetzer Company

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CAN

Quantity affected

24,287 units

Distribution

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

Date initiated

2023-01-03

Date posted

2023-04-12

Location

Westlake, OH