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Recall Observatory FDA recall evidence

Device product

Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.

Z-0047-2017

April 25, 2016

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 74871
Status
Terminated
Classification
Class II
Quantity
165
Official record key
device-enforcement:Z-0047-2017

Official wording

Reason: It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.

Code information: LL 500

Distribution pattern: US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.

Field note

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