Class 2 Device Recall KDR UArm, Bucky and Tubestand

• Date Initiated by Firm: November 08, 2018
• Create Date: December 21, 2018
• Recall Status: Terminated on July 23, 2021
• Recall Number: Z-0659-2019
• Recall Event ID: 81649
• Product Classification: Holder, radiographic cassette, wall-mounted - Product Code IXY
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Konica Minolta Healthcare, Americas, Inc.; 2217 US Highway 70 E; Garner NC 27529-9424
• For Additional Information Contact: Konica Minolta Customer Care Team; 800-945-0456
• Manufacturer Reason for Recall: Unintentional U-Arm movement
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.