Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Toshiba America Medical Systems Recalled by Toshiba American Medical Systems Inc Due to It has been found that if the scan...

Date: April 25, 2016
Company: Toshiba American Medical Systems Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Toshiba American Medical Systems Inc directly.

Affected Products

Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

Quantity: 165

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 35 states: AL, AR, CA, CO, CT, FL, GA, HI, ID, IN, IA, KS, KY, LA, MA, MI, MN, MS, MT, NE, NH, NJ, NM, NY, NC, ND, OH, PA, SC, SD, TN, VT, WA, WV, WI

Affected (35 states)Not affected

About Toshiba American Medical Systems Inc

Toshiba American Medical Systems Inc has 56 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report