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Terminated

O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

FDA Recall Z-2885-2018 · Posted None

Recalling FirmO-Two Medical Technologies, Inc.
Recall StatusTerminated
Product CodeBZR
Date Initiated2018-05-14
Date Terminated2020-06-03
Product Quantity3 units

Reason for Recall

Higher levels of nitrous oxide delivered than specification

Firm Action

O-Two Medical Technologies Inc. issued letter on May 14. 2018 titled: Notice of Product Upgrade of the 0-Two Equinox Relieve Analgesic Gas Delivery System , requesting customers to return their units for inspection and upgrade. Contact via email to [email protected].

Root Cause

Device Design

Distribution Pattern

AK, CA, FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113687EQUINOX RELIEVEO-Two Medical Technologies, Inc. · 2012-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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