Stereotaxis Inc Niobe ES System, Models 001-006000-1 and 001-006100-1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Niobe ES System, Models 001-006000-1 and 001-006100-1
Brand
Stereotaxis Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Stereotaxis Inc is recalling Niobe ES System, Models 001-006000-1 and 001-006100-1 due to There is a potential for fire in the inside computer cabinet.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for fire in the inside computer cabinet.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MI, MN, MO, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI
Page updated: Jan 10, 2026