FDAClass IIJune 11, 2014

Toshiba Infinix X-Ray Interventional System recall

Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an…

Why was Toshiba Infinix X-Ray Interventional System recalled?

Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.

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 Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.

Product
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an…
Recalling firm
Toshiba American Medical Systems Inc
Quantity
2
Distribution
Nationwide Distribution including CA and IN
Recall date
June 11, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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