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Recall Observatory FDA recall evidence

Device product

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

Z-0430-2021

September 21, 2020

Class II

Product summary

Firm
Stereotaxis Inc
Event
Event 86555
Status
Terminated
Classification
Class II
Quantity
121
Official record key
device-enforcement:Z-0430-2021

Official wording

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

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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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