Reported Dec 30, 2015 · Terminated

Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to…

Shimadzu Medical Systems

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Shimadzu Medical Systems · 20101 S Vermont Ave · Torrance, CA · 90502-1328

Is this the product you have?

  • Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
Lot codes and dates
  • Serial No.

    301 of 301 codes

    • 41DBBB534001
    • 41DBBB534004
    • 41DBBB534002
    • 41DBBB534005
    • 41DBBB534006
    • 41DBBB536001
    • 41DBBB536007
    • 41DBBB536008
    • 41DBBB536009
    • 41DBBB536010
    • 41DBBB539001
    • 41DBBB539002
    • 41DBBB539003
    • 41DBBB539004
    • 41DBBB53A001
    • M1DBBB547001
    • M1DBBB547002
    • M1DBBB547003
    • M1DBBB547004
    • M1DBBB547005
    • M1DBBB547006
    • M1DBBB547007
    • M1DBBB548001
    • M1DBBB548002
    • 41DBBA136010
    • 41DBBA136014
    • 41DBBA145008
    • 41DBBA145009
    • 41DBBA145016
    • 41DBBA141006
    • 41DBBA147004
    • 41DBBA149021
    • 41DBBA149022
    • 41DBBA132003
    • 41DBBA142001
    • 41DBBA14A004
    • 41DBBA132001
    • 41DBBA132010
    • 41DBBA141012
    • 41DBBA142012
    • 41DBBA147017
    • 41DBBA147028
    • 41DBBA146015
    • 41DBBA146017
    • 41DBBA142004
    • 41DBBA142014
    • 41DBBA148002
    • 41DBBA131018
    • 41DBBA131020
    • 41DBBA136006
    • 41DBBA136011
    • 41DBBA141013
    • 41DBBA14A010
    • 41DBBA142019
    • 41DBBA142020
    • 41DBBA149005
    • 41DBBA145024
    • 41DBBA143002
    • 41DBBA141009
    • 41DBBA136003
Amount recalled
297 units

Why it was recalled

The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 27, 2016 · Data as of Sep 19, 6:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.