Recall Z-2885-2018 ยท BZR Mixer, Breathing Gases, Anesthesia Inhalation
O-Two Medical Technologies, Inc.
O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
| Date | May 14, 2018 |
| Status | Terminated |
| Reason | Higher levels of nitrous oxide delivered than specification |
| Root cause | Device Design |
| 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 david@otwo.com. |
| Quantity | 3 units |
| Distribution | AK, CA, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113687 | EQUINOX RELIEVE O-Two Medical Technologies, Inc., Apr 30, 2012 |