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Equinox Relieve

O-Two Medical Technologies Inc · Model 01EQ1000F · UDI-DI 07540195040045

BZR Prescription

510(k) clearances

590

Adverse events (9 deaths)

Recalls

Facilities

Description

The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture. It provides two input connectors for connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has a control for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be activated by an inspiratory effort by the patient. The out put of N2O/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture.

Recalls

Date	Firm	Reason
2018-05-15	CAREstream Medical LLC	Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
2018-05-14	O-Two Medical Technologies, Inc.	Higher levels of nitrous oxide delivered than specification
2005-01-11	Maquet Inc	Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.

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Data 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.