Toshiba Angio WorkStation Recalled for Incorrect Skin Dose Calculation
Toshiba is recalling 23 Angio WorkStation systems because a software error caused the displayed Peak Skin Dose to be higher than expected during specific procedures.
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, but the source text describes a software calculation error regarding dose display without reporting any patient injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity issue.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 23 units of the Angio WorkStation (Model XIDF-AWS801) and INFX-8000V Bi-Plane System. The affected software versions are v6.00, v6.01, and V6.10. These devices were distributed to facilities in North Carolina, New York, Texas, Georgia, California, Arizona, Illinois, Florida, Massachusetts, Missouri, and Delaware.
The recall was initiated because the software incorrectly calculated the Peak Skin Dose (PSD) value. This error occurred when the x-ray conditions for the frontal and lateral planes were identical. In these instances, the system displayed a PSD value larger than expected because it incorrectly used a dose value from a previous exposure in the calculation.
Facilities using these systems should contact Toshiba American Medical Systems Inc for instructions on how to resolve the software issue. The recall is limited to the specific software versions and model numbers listed above.
The recalled product
- Product
- Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 23
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)
- Model Number - XIDF-AWS801
Distribution
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