Z-1397-2017Class II

Toshiba Kalare DREX-KL80 X-ray generator

Name: Z-1397-2017 Toshiba Kalare DREX-KL80 X-ray generator
Creator: Toshiba American Medical Systems Inc
Published: 2016-05-19
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2016-05-19 / Terminated

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba Kalare DREX-KL80 X-ray generator on 2016-05-19. FDA classified it as Class II and gives the reason as "It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1397-2017
Classification: Class II
Status: Terminated
Initiated: 2016-05-19
Posted: 2017-03-14
Terminated: 2018-06-14
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba Kalare DREX-KL80 X-ray generator
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
FDA root cause: Radiation Control for Health and Safety Act
Action: Toshiba America Medical Systems planned action to bring defect into compliance : 1. A notification letter will be sent to customers with affected systems. This letter includes the statement that the repairs will be made at no cost to the customer. 2. Modified firmware will be installed on the systems to prevent the defect from recurring. 3. The consignees will be contacted by a Toshiba service representative for an appointment when the modified firmware becomes available 4. The consignee will be informed that if this problem occurs before the new firmware is installed; they should reset the x-ray generator to complete the exam; and 5. The CAP will be completed by May 1, 2017. For further questions please call (714) 730-5000
Quantity in commerce: 254
Distribution: 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.
Product codes and lots: Model : KXO-80XD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1397-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1397-2017	Class II	Terminated	FDA Mandated	2017-03-22	2017-03-14
Z-1398-2017	Class II	Terminated	FDA Mandated	2017-03-22	2017-03-14

Product code JAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)