Toshiba American Medical Systems Inc: Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.

Recall number

Z-2282-2012

Recalling firm

Toshiba American Medical Systems Inc

Product

Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.

Status

Terminated

Initiated

2009-07-13

Posted

2012-08-28

Terminated

2012-09-04

Reason

1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco

Root cause

Software design

Action

The firm, Toshiba America Medical Systems, Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 30, 2009 to its Consignees/customers. The letter described the product, problem and actions to be taken. The letter informed them of the above mentioned reason for recall and telling them that a corrective measure will be installed to prevent the occurrence of the above problems. They were told that their Toshiba service representative will contact them to install the measures. Furthermore Toshiba instructed them to adopt the following temporary measures to avoid these phenomena until corrective measures have been taken. 1. When performing raw data processing for Go&Return helical scan, select the raw data acquired for Go and that acquired for Return separately in order to perform reconstruction 2. When using the Sure Exposure 3D function, confirm that the error message shown in the preceding page is not displayed on the monitor at the time of setup (until the Scan Start button lights after the Confirm button is clicked). 3. When executing an eXam Plan in which Sure Exposure 3D is selected as the actual scan for Sure Start, confirm that the error message show in the preceding page is not displayed on the monitor when monitoring scan is switched to the actual scan. If the error message is displayed, click [OK] in the error message dialog to continue processing. The letter should be shared with facility's Biomedical or Clinical Engineering Department. Also the customers were instructed to complete and return the Customer Reply Form via fax to: Regulatory Affairs at 877-349-3054. If you have any questions regarding this letter, contact Director, Regulatory Affairs at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968 with any questions regarding the letter.

Quantity

24 Systems

Distribution

Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico.

Lot, serial or model codes

Serial Number: 2DA0882051

510(k) numbers

["K072606"]

PMA numbers

not on file

Product code

JAK

Firm FEI

2020563

Firm city

Tustin

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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