Z-0012-2018Class II

Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal...

Name: Z-0012-2018 Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal...
Creator: Toshiba American Medical Systems Inc
Published: 2017-09-12
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2017-09-12 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and... on 2017-09-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0012-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-12
Posted: 2017-10-17
Terminated: 2020-11-18
Recalling firm: Canon Medical Systems USA, Inc.
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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
Root cause tag: software
FDA 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 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. Thank you for your urgent attention to this matter. If you have any questions regarding this letter please feel free to call (800) 421-1968, or contact your local Toshiba Representative at (800) 521-1968. For further questions please call (714) 730-5000.
Quantity in commerce: US - 96
Distribution: USA (nationwide) Distribution
Product codes and lots: Model: HDR-08A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0012-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0012-2018	Class II	Terminated	FDA Mandated	2017-10-25	2017-10-17

Product code JAA

K133553Class IIKalareToshiba America Medical Systems, In.C / cleared 2014-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)