Recall Z-0806-2020 ยท KPR System, X-Ray, Stationary
Carestream Health, Inc.
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.
| Date | Jan 6, 2020 |
| Status | Terminated |
| Reason | Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm. |
| Root cause | Component change control |
| Action | On January 6, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Users were informed that they may continue to use the system at this time. However, until the correction is executed, Carestream Health strongly recommends against performing any equipment positioning while the patient is near the system to avoid any bodily injury. If the user of the equipment observes any abnormal displacement in the vertical axis during the vertical movement, the device should be removed from use and a service call placed to Carestream (or local dealer) without delay. A |
| Quantity | 79 |
| Distribution | Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060550 | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 Eastman Kodak Company, Mar 31, 2006 |