Konica Minolta Healthcare, Americas, Inc.: Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical 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.

Recall number

Z-0659-2019

Recalling firm

Konica Minolta Healthcare, Americas, Inc.

Product

Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical 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.

Status

Terminated

Initiated

2018-11-08

Posted

not on file

Terminated

2021-07-23

Reason

Unintentional U-Arm movement

Root cause

Device Design

Action

On 11/08/2018, the firm send a letter titled;" IMPORTANT PRODUCT INFORMATION", regarding the Konica Minolta KDR U-Arm. Potential unintentional U-Arm movement due to the tablet enclosure buttons, located on the tablet enclosure, remaining engaged after being depressed. The firm included a document titled, KDR U-ARM Tablet Enclosure FAQ as part of the IMPORTANT PRODUCT INFORMATION. The firm is preparing to issue an Interim Corrective Action; Disabling the buttons contained on the KDR tablet enclosure and a Final Corrective Action; A modification to the mounting of the PCB - which contains the drive buttons will reduce the potential of the event -this will help assure the buttons make the proper contact without staying depressed. In addition, the firm issued a "Technical Bulletin-Business Partner for the Product: KDR U-Arm Tablet Enclosure." The preliminary notification was sent to dealer partners which require all Partners to take immediate action. There are two critical actions needed to mitigate this risk: 1. Interim Action (Immediate Action Required): The firm has released an immediate field corrective action to temporarily disconnect the tablet enclosure buttons. Instructions can be found in KON-000127 . 2. Final Action (Anticipated Release January 2019): A modification to the tablet design will help ensure the buttons make the proper contact without staying depressed. The Interim Action/Field Correction is required to be completed by December 15, 2018. Contact Konica Minolta Dispatch department at 1- 800-945-0456 to schedule a Konica Minolta Engineer to complete Corrective action. For each affected unit, it is important that your engineer performs the following: 1. Complete the Tablet Button Disconnection procedure - KON-000127 2. Fill out form KON-000157 (Customer Signature required) 3. Take a picture of the completed form KON-000157 and email to ServiceBilling@gcp.konicaminolta .com.

Quantity

151

Distribution

US Nationwide Distribution: AL; CA; CO; FL; GA; IA; IL; IN; KY; LA; MA; MI; MN; MO; NC; NH; NY; OH; OK; PA; SC; TN; TX; and VA.

Lot, serial or model codes

SU4000 AU 4000 U ARM Item Number DR-4000-MTB  Serials Numbers/Lot Numbers: SU41607003; SU41607004; SU41607005; SU41607006; SU41607008; SU41607009; SU41607010; SU41607011; SU41612012; SU41612013; SU41612014; SU41612015; SU41612016; SU41612017; SU41612018; SU41612019; SU41612020; SU41612021; SU41702006; SU41702007; SU41702009; SU41703010; SU41703011; SU41703012; SU41703013; SU41703015; SU41704016; SU41704017; SU41704019; SU41704020; SU41704021; SU41704022; SU41704023; SU41704024; SU41704025; SU41705026; SU41705027; SU41705028; SU41705029; SU41705031; SU41705032; SU41705033; SU41705034; SU41705035; SU41707036; SU41707038; SU41707039; SU41707040; SU41707041; SU41707042; SU41707043; SU41707044; SU41708046; SU41708047; SU41708048; SU41708049; SU41708050; SU41708051; SU41708052; SU41708053; SU41708054; SU41708055; SU41709060; SU41709061; SU41709062; SU41709063; SU41709064; SU41709065; SU41709066; SU41709068; SU41709069; SU41711070; SU41711071; SU41711072; SU41711073; SU41711074; SU41711075; SU41711076; SU41711077; SU41711079; SU41711080; SU41711081; SU41711082; SU41711083; SU41711084; SU41711085; SU41711086; SU41711087; SU41711088; SU41711089; SU41712090; SU41712093; SU41712094; SU41712095; SU41712096; SU41712097; SU41712098; SU41712099; SU4172091; SU41801001; SU41801002; SU41801003; SU41801004; SU41801005; SU41802006; SU41802007; SU41802008; SU41802009; SU41802010; SU41802011; SU41802012; SU41802013; SU41802014; SU41802015; SU41802016; SU41802017; SU41802018; SU41802019; SU41802020; SU41803021; SU41803022; SU41803023; SU41803024; SU41803025; SU41803026; SU41803028; SU41803029; SU41803030; SU41803031; SU41803032; SU41803033; SU41803034; SU41803035; SU41803037; SU41803038; SU41803039; SU41803040; SU41806041; SU41806042; SU41806043; SU41806044; SU41808047; SU41808048; SU41808049; SU41808050; SU41808053; SU41808054; SU41808055; SU41808058; SU41808060; SU41808063; SU41808064

510(k) numbers

not on file

PMA numbers

not on file

Product code

IXY

Firm FEI

3002885429

Firm city

Garner

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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