Z-0430-2021Class II

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

Name: Z-0430-2021 Niobe ES System, Models 001-006000-1 and 001-006100-1
Creator: Stereotaxis Inc
Published: 2020-09-21
License: https://open.fda.gov/license/

Stereotaxis Inc / initiated 2020-09-21 / Terminated / root cause: design

FDA source

Stereotaxis Inc began a recall of Niobe ES System, Models 001-006000-1 and 001-006100-1 on 2020-09-21. FDA classified it as Class II and gives the reason as "There is a potential for fire in the inside computer cabinet". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0430-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-21
Posted: 2020-11-06
Terminated: 2023-11-13
Recalling firm: Stereotaxis Inc
Product: Niobe ES System, Models 001-006000-1 and 001-006100-1
Product code: PJB Catheter Remote Control System
Reason for recall: There is a potential for fire in the inside computer cabinet.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 121
Distribution: 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
Product codes and lots: Devices with the following system numbers (serial): 105, 108, 113, 116, 124, 125, 126, 128, 130, 131, 134, 135, 138-142, 144, 147, 149, 154, 158, 162, 163, 169, 170, 172-174, 177-179, 181-183, 185, 187, 189, 190, 192-202, 205, 206, 208-210, 212, 214-222, 224-229, 231, 232, 235-242, 244, 245, 249, 251-256, 258-278, 280-284, 286, 287, 288, 290, and 297

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0430-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0430-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-18	2020-11-06

Product code PJB

K192775Class IINiobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc. / cleared 2019-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)