Z-1175-2016Class II

Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use with the...

Name: Z-1175-2016 Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use with the...
Creator: Toshiba American Medical Systems Inc
Published: 2016-01-14
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2016-01-14 / Terminated

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use with the ceiling-suspended tube support, high voltage generator, and... on 2016-01-14. FDA classified it as Class II and gives the reason as "When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the "OK"...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1175-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-14
Posted: 2016-03-21
Terminated: 2017-02-24
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the "OK" button to re-acquire the image data or to select the'Cancel" button to cancel the re-acquisition. As instructed the user selected "OK" and the same message window appeared. This same operation was repeated several times with the identical result - no image. Finally, the user selected "Cancel" and the re-acquisition was terminated.
FDA root cause: Radiation Control for Health and Safety Act
Action: Toshiba's planned action: 1."Toshiba America Medical Systems, Inc. (TAMS) will advise contact customers to stop using the system if any abnormalities are found using the system. 2. TAMS will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that TAMS will without charge, remedy the defect or bring the product into compliance. 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 noted below are to be included in the notification. 2. TAMS will implement this CAP by June 30, 2016. Customers with questions were advised to call 301-796-5910. For questions regarding this recall call 714-730-5000.
Quantity in commerce: 28
Distribution: Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
Product codes and lots: Serial number : USB1522023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1175-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1175-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-21

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)