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.

Unintentional U-Arm movement

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 [email protected] .com.