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Terminated

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

FDA Recall Z-2392-2016 · Posted None

Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-06-30
Date Terminated2016-11-01
Product Quantity33 units

Reason for Recall

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.

Firm Action

Hitachi sent an Device Correction Notice dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were informed that there is a problem with the Hitachi Medical Systems America, Inc.CT system; the issue is with a power supply in the CT gantry sub-system. During fast rotation (i.e., 35 sec), the centrifugal force applied to the power supply may cause it to fail over time. For further questions, please call (330) 425-1313 ext. 3720.

Root Cause

Component design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101888SCENARIA WHOLE-BODY X-RAY CT SYSTEMHitachi Medical Systems America, Inc. · 2011-04-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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