FDA Device

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

Hazard

There is a potential for fire in the inside computer cabinet.

What You Should Do

Remedy

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.

Products

Niobe ES System, Models 001-006000-1 and 001-006100-1
Brand
Stereotaxis Inc
UPC
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

Units Affected

121