Toshiba American Medical Systems Inc: Medical Device Recall in 2012 - (Recall #: Z-2282-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 13, 2009

Date Posted: September 5, 2012

Recall Number: Z-2282-2012

Event ID: 53055

Reason for Recall:

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

Status: Terminated

Product Quantity: 24 Systems

Code Information:

Serial Number: 2DA0882051

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated