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Recall Observatory FDA recall evidence

Device product

Toshiba Aquilion CT System TSX-301A

Z-0014-2016

May 08, 2015

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 71923
Status
Terminated
Classification
Class II
Quantity
459
Official record key
device-enforcement:Z-0014-2016

Official wording

Reason: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

Code information: system software V6.0 or later

Distribution pattern: US Distribution including Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.