FDA Device recall Z-0210-2018
SMARTABLATE RF System Generator
- FDA Device
- Class II
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class II recall of SMARTABLATE RF System Generator by Biosense Webster, citing generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0210-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-14 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biosense Webster |
| Distribution | CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI |
Product
SMARTABLATE RF System Generator
Reason
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Identifiers
| code_info | Product Codes M490006, M490007 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Biosense Webster
- VARIPULSE Bi-Directional Ablation Catheter REF D141201
FDA Device · Class I · 2025-03-12 · Biosense Webster - CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibili…
FDA Device · Class II · 2024-03-20 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501
FDA Device · Class II · 2022-09-14 · Biosense Webster
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0210-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.