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Allied Medical, LLC · Model T12104 · UDI-DI 00026072025697
10
510(k) clearances
646
Adverse events (23 deaths)
17
Recalls
113
Facilities
Description
GUARD,WIREFORM,REGARD-II
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-01-03 | Western/Scott Fetzer Company | 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 wi |
| 2021-10-16 | Western/Scott Fetzer Company | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke |
| 2021-10-16 | Western/Scott Fetzer Company | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke |
| 2021-10-16 | Western/Scott Fetzer Company | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke |
| 2018-05-08 | Dynarex Corporation | The device is equipped with a dial that has an inaccurate flow rate indicator. |
| 2015-10-08 | Precision Medical, Inc. | These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter |
| 2015-01-31 | Western / Scott Fetzer Company | The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death. |
| 2014-04-07 | Western / Scott Fetzer Company | Separation events have occurred, including the VIPR separating from the Aluminum cylinder. |
| 2013-03-08 | Linde Gas North America Llc | A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs. |
| 2012-11-16 | Praxair Inc. | Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.