MalfunctionGXD
IonicRF¿ Generator
Received Jul 27, 2026 · Event occurred Jun 26, 2026
Report 2184149-2026-00207 · MDR key 50001651
Device
Generic name
Rfg-ionic
Manufacturer
Abbott Medical (af-st. Paul)Model number
RFG-IONICCatalog number
RFG-IONIC
Lot number
8242646
Product problems
- Failure of Device to Self-Test
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported an ablation procedure was abandoned due to the Ionic failed during self-diagnostic testing. There was no adverse effect.
Additional Manufacturer Narrative
Date of event is estimated.E1 - Reporter Phone Number: (b)(6).