Recall Z-0012-2018 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Toshiba American Medical Systems Inc
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 qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whol
| Date | Sep 12, 2017 |
| Status | Terminated |
| Reason | During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk. |
| Root cause | Software design |
| Action | Toshiba planned action to bring defect into compliance: 1. You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2. You will install modified firmware on the systems to correct the defect and prevent recurrence. 3. You will provide progress reports on the effectiveness of the plan. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within |
| Quantity | US - 96 |
| Distribution | USA (nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133553 | KALARE Toshiba America Medical Systems, In.C, Jun 13, 2014 |