Device product
Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator shutter are accomplished at the operator console.
Z-0806-2020
Product summary
- Event
- Event 84616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79
- Official record key
device-enforcement:Z-0806-2020
Official wording
Reason: Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Code information: DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093
Distribution pattern: Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
Derived failure modes
-
Unknown
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.