Toshiba Kalare Diagnostic X-Ray System Recalled for Image Quality Defect
Toshiba American Medical Systems is recalling 153 Kalare Diagnostic X-Ray Systems because the large focus heats up unexpectedly, causing brighter images than expected.
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 a voluntary precautionary action by the firm for a functional defect that affects image quality (brightness) but does not involve reported injuries, fatalities, or high-risk pathogens.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 153 units of the TOSHIBA Kalare Diagnostic X-Ray System (K110785) distributed nationwide in the United States. The recall was initiated by the firm due to a defect in the equipment's operation.
The issue occurs when radiographic conditions with the small focus are set and the radiography ready switch is held down while using the Automatic Exposure Function (AEC). In these instances, the large focus is also heated after a few seconds or more. This causes a radiographic tube current exceeding the set value to flow, resulting in a brighter image than expected being acquired.
The source text does not specify instructions for consumers or healthcare providers on how to resolve the issue, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- TOSHIBA Kalare Diagnostic X-Ray System K110785
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 153
Distribution
Distributed nationwide across the United States.
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