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Recall Observatory FDA recall evidence

Device 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.

Z-2282-2012

July 13, 2009

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 53055
Status
Terminated
Classification
Class II
Quantity
24 Systems
Official record key
device-enforcement:Z-2282-2012

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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