Niobe ES System, Models 001-006000-1 and 001-006100-1
- Company
- Stereotaxis Inc
- Recall Initiated
- September 21, 2020
- Terminated
- November 13, 2023
- Recall Number
- Z-0430-2021
- Quantity
- 121
- Firm Location
- Saint Louis, MO
Reason for Recall
There is a potential for fire in the inside computer cabinet.
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
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.