FDAClass IIAugust 17, 2016

Hitachi Scenaria Computed Tomography System Hitachi recall

Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087

Why was Hitachi Scenaria Computed Tomography System Hitachi recalled?

The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.

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 #'s: S5002-S5014; S5017-S5038

Product
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Recalling firm
Hitachi Medical Systems America Inc
Quantity
33 units
Distribution
US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
Recall date
August 17, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls