The Recall Desk
ModerateFDA (Devices)·Z-0047-2017·Announced 2016-10-12

Toshiba Aquilion RXL CT Scanner Recalled for Reconstruction Error

Toshiba is recalling 165 Aquilion RXL CT scanners because a reconstruction error may interrupt scans 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, but the source explicitly states the issue has not occurred in the U.S. and the hazard is a system interruption rather than a direct physical injury, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Toshiba America Medical Systems, Inc. is recalling 165 Aquilion RXL TSX-101 A/R, U CT Scanners. These diagnostic imaging systems are indicated to acquire and display cross-sectional volumes of the whole body, including the head.

The recall is due to a potential reconstruction operation error that may occur if the scan range extends beyond the maximum Field of View (FOV). This error may result in the scanning process being interrupted, requiring the system to be rebooted. The source text notes that this specific issue has not occurred in the United States.

The affected units were distributed to facilities in the following states: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, GA, MT, NM, VT, TN, CA, NH, NJ, NE, SC, and KS. Healthcare facilities should contact Toshiba for instructions on how to address the issue.

The recalled product

Product
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Manufacturer
Toshiba American Medical Systems Inc
Category
Medical Device — Diagnostic Imaging
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)

  • LL 500

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 →

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