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Recall Observatory FDA recall evidence

Device product

INFX-8000H Fluoroscopic X-Ray Systems

Z-0845-2018

December 29, 2017

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 79153
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0845-2018

Official wording

Reason: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

Code information: Serial Numbers: A5B1672001, AFA1692002

Distribution pattern: United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.