FDAClass IIMarch 30, 2016

Toshiba DRAD-3000E FPD Wireless System Product Usage recall

Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage…

Why was Toshiba DRAD-3000E FPD Wireless System Product Usage recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial number : USB1522023

Product
Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage…
Recalling firm
Toshiba American Medical Systems Inc
Quantity
28
Distribution
Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
Recall date
March 30, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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