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Recall Observatory FDA recall evidence

Device product

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

Z-2885-2018

May 14, 2018

Class II

Product summary

Firm
O-Two Medical Technologies, Inc.
Event
Event 80414
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-2885-2018

Official wording

Reason: Higher levels of nitrous oxide delivered than specification

Code information: Serial Number: EQ1332-17, EQ3001-18, EQ3003-18

Distribution pattern: AK, CA, FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Higher levels of nitrous oxide delivered than specification