Recall Z-0659-2019 ยท IXY Holder, Radiographic Cassette, Wall-Mounted
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
| Date | Nov 8, 2018 |
| Status | Terminated |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.