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Terminated

Hitachi Scenaria Whole-body X-ray CT System

FDA Recall Z-0271-2020 · Posted None

Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2019-10-16
Date Terminated2020-04-30
Product Quantity39

Reason for Recall

There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.

Firm Action

An Urgent Medical Device Correction Notice dated 10/15/19 was sent to customers. Hitachi will inspect all heat controller units for Scenaria systems S5002-S5014 and S5017-S5044 to ensure that the cables and cable loop clamp are affixed as instructed and apply modifications as needed. We expect to begin this process in late October I early November 2019. This action will be implemented by Hitachi Service at no charge to you. Your Service Area Manager will contact you for scheduling. Please contact me if you need further information regarding this report. You can send any questions, comments or requests to [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR. The products were distributed to the following foreign countries: 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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