Moderate FDA (Devices)·Z-0972-2014·Announced 2014-03-12

Toshiba CT System Recalled Due to X-Ray Generator Failure

Toshiba is recalling eight Aquilion One CT systems because high-voltage generator parts may fail, preventing X-ray exposure.

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 describes a functional failure preventing X-ray exposure rather than a hazard causing injury or death, fitting the criteria for a moderate severity voluntary recall.

Plain-English summary

Toshiba America Medical Systems, Inc. is recalling eight units of the TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. The recall was initiated due to the failure of parts used in the X-ray high-voltage generator.

In some cases, this failure means that X-ray exposure cannot be performed. The affected units were distributed in the United States, including the states of Maryland, West Virginia, Ohio, California, Minnesota, Indiana, New York, and Wisconsin.

Healthcare facilities should contact Toshiba America Medical Systems, Inc. for further instructions regarding the repair or replacement of the affected equipment.

The recalled product

Product: TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Manufacturer: Toshiba American Medical Systems Inc
Category: Medical Device — Computed Tomography
Hazard: equipment-failure
Affected units: 8

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 (10)

SERIAL NO.: 1CB1262006
1DB1312033
1DC1352070
1DB1342060
1DB1332049
1DC1382081
1DB1312027
1DB1332045
1DC1362073
1CB12X2018.

Distribution

Distributed in 8 states:

Same manufacturer · Toshiba American Medical Systems Inc

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