FDA Device recall Z-0012-2018
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for rad…
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for rad… by Toshiba American Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0012-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-12 |
| Published | 2017-10-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
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.
Identifiers
| code_info | Model: HDR-08A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0012-2018%22
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