Reported Dec 26, 2018 · Terminated

Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced…

Konica Minolta Healthcare, Americas, Inc.

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: Konica Minolta Healthcare, Americas, Inc. · 2217 US Highway 70 E · Garner, NC · 27529-9424

Is this the product you have?

  • Bucky Stand SU-4000 Input 2017.11.17
  • SU41711085 Date2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of
  • the following associated subassembliesVertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit
Lot codes and dates

152 of 152 products

Products covered by this recall
Model / numberProduct as published
DR-4000-MTBSU4000 AU 4000 U ARM Serials Numbers/Lot Numbers: SU41607003
—SU41607004
—SU41607005
—SU41607006
—SU41607008
—SU41607009
—SU41607010
—SU41607011
—SU41612012
—SU41612013
—SU41612014
—SU41612015
—SU41612016
—SU41612017
—SU41612018
—SU41612019
—SU41612020
—SU41612021
—SU41702006
—SU41702007
Amount recalled
151

Where it was sold

Why it was recalled

Unintentional U-Arm movement

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 23, 2021 · Data as of Nov 7, 2:00 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.