SMARTABLATE RF System Generator — Class II medical device recall Z-0210-2018
Terminated recall by Biosense Webster, Inc., reported 2017-12-13, distributed in CA, CO, GA, IL, IN, MI, NM, NY…. Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented towa
| Recall number | Z-0210-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2017-06-14 |
| Classified | 2017-12-07 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2021-01-11 |
| Distributed | CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI |
| Countries outside the US | AT, BE, DE, DK, FR, IT, SE, SG |
| Quantity | 185 units |
Product
SMARTABLATE RF System Generator
Reason for recall
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0210-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.