Toshiba American Medical Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-0047-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 25, 2016

Date Posted: October 12, 2016

Recall Number: Z-0047-2017

Event ID: 74871

Reason for Recall:

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.

Status: Terminated

Product Quantity: 165

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.

Voluntary or Mandated:

FDA Mandated