Toshiba Ultimax X-ray generator recalled for premature exposure termination
Toshiba American Medical Systems is recalling 254 Ultimax DREX-ULT80 X-ray generators because the system may terminate exposure prematurely during an examination.
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 3/5 (High).
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 involves a medical device with a defect that could lead to improper exposure during an examination. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 254 units of the Toshiba Ultimax DREX-ULT80 X-ray generator (Model KXO-80XM). The recall was initiated because it was discovered that the generator of the system 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 Ultimax DREX-ULT80 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-80XM
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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- HighToshiba INFX-8000F Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
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- HighToshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
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Same hazard · premature exposure termination
See all →- HighToshiba Kalare X-ray Generator Recalled for Premature Exposure Termination
FDA (Devices) · 2017-03-22
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