FDAFDA · Food and drugs·Recall number Z-1397-2017
Toshiba Kalare DREX-KL80 X-ray generator
Published March 22, 2017 · Recall initiated: May 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems Inc
- Distributor
- USA ( nationwide ) Distribution to the states of : 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, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.
- Lot
- Model : KXO-80XD
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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