Recall Z-0012-2018— Toshiba American Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2017-09-12, terminated 2020-11-18. It names one FDA 510(k) clearance: K133553. 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 qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.. 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..
- Recalling firm
- Toshiba American Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-12
- Terminated
- 2020-11-18
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.