Toshiba Celesteion CT Scanner Recalled for Potential Reconstruction Errors
Toshiba is recalling 165 Celesteion CT scanners because a reconstruction error may interrupt scanning if the scan 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 or death, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Toshiba America Medical Systems, Inc. is recalling 165 units of the Celesteion PCA-9000A/2 CT Scanner. 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 can result in scanning being interrupted and may require the system to be rebooted.
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. The source text notes that this specific issue has not occurred in the U.S.
Healthcare facilities should contact Toshiba America Medical Systems, Inc. for instructions on how to address the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
- Manufacturer
- Toshiba American Medical Systems Inc
- 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
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.
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