Toshiba Medical Kalare Fluoroscopic X-Ray System Recalled for Image Display Failure
Toshiba American Medical Systems Inc is recalling 96 Kalare Fluoroscopic X-Ray Systems because images may fail to display on the system monitor or save to the hard disk.
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 functional defect (image display/saving failure) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 96 units of the Toshiba Medical Kalare Fluoroscopic X-Ray System (Model DREX-KL80) in the United States. The recall is due to a defect where images displayed on the live monitor during an examination may not be displayed on the system monitor or saved to the hard disk.
The affected units are distributed nationwide. The Kalare system is intended for use by qualified doctors or technologists for radiographic and fluoroscopic examinations of adult and pediatric subjects.
Consumers and healthcare facilities should contact Toshiba American Medical Systems Inc for further information regarding the recall and corrective actions.
The recalled product
- Product
- Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by…
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 96
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: HDR-08A
Distribution
Distributed nationwide across the United States.
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