Recall Z-0430-2021— Stereotaxis Inc

Name: FDA recall Z-0430-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-21

Class II · Terminated

Class II FDA medical device recall by Stereotaxis Inc, initiated 2020-09-21, terminated 2023-11-13. It names one FDA 510(k) clearance: K192775. Product: Niobe ES System, Models 001-006000-1 and 001-006100-1. Reason: There is a potential for fire in the inside computer cabinet..

Recalling firm: Stereotaxis Inc
Classification: Class II
Status: Terminated
Initiated: 2020-09-21
Terminated: 2023-11-13
Firm location: Saint Louis, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K192775 — Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc.·cleared 2019-10-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.