Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Niobe ES System, Models 001-006000-1 and 001-006100-1

FDA Recall Z-0430-2021 · Posted None

Recalling FirmStereotaxis Inc
Recall StatusTerminated
Product CodePJB
Date Initiated2020-09-21
Date Terminated2023-11-13
Product Quantity121

Reason for Recall

There is a potential for fire in the inside computer cabinet.

Firm Action

The firm will be contacting consignees via email and providing an electronic Urgent Field Safety Notice and Customer Reply Form. Consignees are asked for return the acknowledgement form to the firm within 30 days of receipt.

Root Cause

Device Design

Distribution Pattern

US and OUS distribution: US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA OUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc. · 2019-10-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑