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U.S. Department of Health and Human Services

Class 2 Device Recall Niobe ES

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 Class 2 Device Recall Niobe ESsee related information
Date Initiated by FirmSeptember 21, 2020
Create DateNovember 06, 2020
Recall Status1 Terminated 3 on November 13, 2023
Recall NumberZ-0430-2021
Recall Event ID 86555
510(K)NumberK192775 
Product Classification Catheter remote control system - Product Code PJB
ProductNiobe ES System, Models 001-006000-1 and 001-006100-1
Code Information 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
Recalling Firm/
Manufacturer		 Stereotaxis Inc
4320 Forest Park Ave Ste 100
Saint Louis MO 63108-2979
For Additional Information ContactAdam Miller
314-678-6100
Manufacturer Reason
for Recall		There is a potential for fire in the inside computer cabinet.
FDA Determined
Cause 2		Device Design
ActionThe 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 Commerce121
DistributionUS 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PJB
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