Recall Z-0659-2019— Konica Minolta Healthcare, Americas, Inc.
Class II · Terminated
Class II FDA medical device recall by Konica Minolta Healthcare, Americas, Inc., initiated 2018-11-08, terminated 2021-07-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Unintentional U-Arm movement.
- Recalling firm
- Konica Minolta Healthcare, Americas, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-08
- Terminated
- 2021-07-23
- Firm location
- Garner, NC, United States
Product description
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.
Reason for recall
Unintentional U-Arm movement
Data sourced from openFDA. This site is unofficial and independent of the FDA.