Toshiba Infinix-i X-Ray System Recalled for Software Image Error
Toshiba is recalling 95 Infinix-i X-Ray systems because a software error may display incorrect images or cause image loss during fluoroscopy.
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. The hazard involves potential diagnostic errors due to incorrect image display or loss, which is a significant quality issue but does not involve direct physical injury or death, fitting the Moderate category for non-physical device defects.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 95 units of the Toshiba Infinix-i X-Ray System. These are radiographic and fluoroscopic x-ray systems used for diagnostic and angiographic procedures. The units were distributed nationwide in the United States.
The recall is due to a software error that may occur when using the "F-Rec" fluoroscopy image acquisition recording option in "manual mode." This infrequent error may cause images from a different study to be displayed on the monitor. Additionally, acquired images may be lost, which may require additional image acquisitions to be performed.
No specific instructions for consumers are provided in the source text, but the recall affects 95 specific units identified by serial number and manufacture date. Healthcare facilities should verify their equipment against the provided serial number list to determine if their units are affected.
The recalled product
- Product
- Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 95
Distribution
Distributed nationwide across the United States.
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