The Recall Desk
ModerateFDA (Devices)·Z-2282-2012·Announced 2012-09-05

Toshiba Whole Body X-ray Scanner Recalled for Incorrect Data Display

Toshiba is recalling 24 whole body X-ray scanners because incorrect couch positions and scan times may be displayed on reconstructed images.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a software/data processing defect.

Plain-English summary

Toshiba American Medical Systems Inc is recalling 24 whole body X-ray scanners, specifically the whole body volume CT system. The recall was initiated because of a defect in raw data processing for Go&Return helical scanning. When raw data from the first scan (Go) and the second scan (Return) are selected and reconstructed simultaneously, the system may display incorrect couch positions and scan times on the reconstructed images for the data acquired during the Return scan.

The affected systems were distributed nationwide in the United States, including the states of Alabama, Arkansas, California, Colorado, Florida, Georgia, Kentucky, Massachusetts, Maryland, Montana, North Dakota, New Jersey, Nevada, New York, Ohio, Pennsylvania, and Puerto Rico. The specific serial number associated with the recall is 2DA0882051.

Healthcare facilities should contact Toshiba American Medical Systems Inc for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

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.
Manufacturer
Toshiba American Medical Systems Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number: 2DA0882051

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Related recalls

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