Recall Z-0203-2024 ยท GXY Electrode, Cutaneous
Coapt LLC
Coapt Dome Electrode, Gen2 system, cutaneous electrode
| Date | Oct 31, 2023 (initiated Oct 2, 2023) |
| Status | Open, Classified |
| Reason | Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged. |
| Root cause | Process design |
| Action | Coapt, LLC issued a Medical Device Correction notice to its consignees on 10/02/2023 via email. The notice explained the problem, risk, and urged users to take precautions as described in the most recent handbook: https://coaptengineering.com/clinicians. The handbook is under "Downloadable product handbooks." |
| Quantity | 247 devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190416 | Dome Electrode Coapt, LLC, Apr 4, 2019 |