FDAClass IISeptember 20, 2017

Toshiba Medical Radrex - i Digital Radiography X-ray recall

Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high…

Why was Toshiba Medical Radrex - i Digital Radiography X-ray recalled?

It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.

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 No. W8B1572022

Product
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high…
Recalling firm
Toshiba American Medical Systems
Quantity
140
Distribution
USA (nationwide) Distribution
Recall date
September 20, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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