Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The syste...
FDA Recall #Z-2282-2012 — Class II — July 13, 2009
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.
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
Recalling Firm
Toshiba American Medical Systems Inc — Tustin, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
Serial Number: 2DA0882051
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated