Toshiba INFX-8000V X-Ray System Recalled for Dose Meter Error
Toshiba is recalling four INFX-8000V Bi-Plane X-Ray Interventional Systems because a software error caused dose data to be lost during specific imaging 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 data loss issue without reporting any patient injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Toshiba American Medical Systems Inc is recalling four units of the INFX-8000V Bi-Plane X-Ray Interventional System. The recall affects units with serial numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018. These devices were distributed to facilities in Ohio and New York.
The recall was initiated because a software error occurred when a frontal Digital Angiography (DA) acquisition was performed. Scattered x-ray reached the dose meter on the lateral side, causing the meter to send a negative value to the software. The software interpreted this as an abnormal value, stopped displaying dose data, and resulted in the loss of that data. A message stating "Dose meter abnormal, Dose info disabled" was displayed on the system.
Facilities that possess these specific serial numbers should contact Toshiba American Medical Systems Inc for further instructions on how to resolve the issue.
The recalled product
- Product
- INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 4
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 (4)
- Serial Numbers ACA1492002
- AAA1492001
- W4B1442020
- and W4B1432018.
Distribution
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