The Recall Desk
ModerateFDA (Devices)·Z-0048-2017·Announced 2016-10-12

Toshiba Aquilion LB CT Scanner Recalled for Reconstruction Error

Toshiba is recalling 165 Aquilion LB CT scanners because a reconstruction error may interrupt scanning if the range exceeds the maximum field of view.

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. The hazard involves a system interruption and reboot requirement rather than a direct physical injury or death, and the source explicitly states the issue has not occurred in the U.S., fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Toshiba America Medical Systems, Inc. is recalling 165 units of the Aquilion LB TSX-201A/2, 3 CT Scanner. The recall covers units distributed to 38 states across the United States.

The recall was initiated because a reconstruction operation error may occur if the scan range extends beyond the maximum Field of View (FOV). This error can interrupt scanning and may require the system to be rebooted. The source text notes that this specific issue has not occurred in the U.S.

Healthcare facilities using these scanners should contact Toshiba for further instructions on how to address the potential software error.

The recalled product

Product
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Manufacturer
Toshiba American Medical Systems Inc
Category
Medical Device — CT Scanner
Hazard
Affected units
165

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)

  • XL 700

Distribution

Distributed in 35 states:

Part of a larger recall action

This product is one of 4 recalled by Toshiba American Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Toshiba American Medical Systems Inc

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Same hazard · software error

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