Recall Z-0430-2021
Stereotaxis Inc · initiated September 21, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Niobe ES System, Models 001-006000-1 and 001-006100-1
Codes / 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
Reason for recall
There is a potential for fire in the inside computer cabinet.
FDA-determined 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.
Details
- Recall number
- Z-0430-2021
- Initiated
- September 21, 2020
- Terminated
- November 13, 2023
- Product code
- PJB – Catheter Remote Control System
- Quantity
- 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
- Recalling firm
- Stereotaxis Inc, Saint Louis, MO