Toshiba Kalare X-ray Generator Recalled for Premature Exposure Termination
Toshiba American Medical Systems Inc is recalling 254 Kalare DREX-KL80 X-ray generators because the system may terminate exposure prematurely during an examination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (premature termination of X-ray exposure) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 254 units of the Toshiba Kalare DREX-KL80 X-ray generator (Model KXO-80XD). The recall was initiated because it was discovered that the generator could possibly terminate the exposure prematurely during an examination.
The affected units were distributed nationwide to the following states and districts: WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH, FL, AZ, and ND.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Toshiba Kalare DREX-KL80 X-ray generator
- Manufacturer
- Toshiba American Medical Systems Inc
- Category
- Medical Device — X-ray Generator
- Affected units
- 254
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 : KXO-80XD
Distribution
Part of a larger recall action
This product is one of 2 recalled by Toshiba American Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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Same hazard · premature exposure termination
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