Toshiba Angio WorkStation Recalled for Dose Tracking Display Error
Toshiba is recalling 70 Angio WorkStation units because the Peak Skin Dose value may display incorrectly if the workstation is powered on after the Infinix system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the source text describes a display error without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 70 Angio WorkStation (XIDF-AWS801) units used with Infinix Systems (INFX-8000V, INFX-8000C, INFX-8000F). The recall is due to a software issue in the Dose Tracking System (DTS) where the displayed Peak Skin Dose (PSD) value may be larger than the expected value. This specific error occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
The affected units were distributed to facilities in the following US states: LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA, WA, AR, NJ, MD, OK, IN, and NH. The source text identifies a specific serial number (8181622393) associated with the issue.
Healthcare facilities should contact Toshiba American Medical Systems Inc for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 70
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)
- S/N : 8181622393
Distribution
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