Hitachi Medical Systems America Inc: Medical Device Recall in 2019 - (Recall #: Z-0271-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Hitachi Scenaria Whole-body X-ray CT System

Product Classification:

Class II

Date Initiated: October 16, 2019

Date Posted: November 13, 2019

Recall Number: Z-0271-2020

Event ID: 84133

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.

Status: Terminated

Product Quantity: 39

Code Information:

Scenaria units S5002-S5014, S5017-S5044

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.

Voluntary or Mandated:

Voluntary: Firm initiated