Recall Z-2137-2014 ยท KPR System, X-Ray, Stationary
Carestream Health Inc.
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
| Date | Aug 1, 2014 (initiated May 30, 2014) |
| Status | Terminated |
| Reason | A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Recall Letters (dated 5/29/2014) were sent to the consignees on 5/30/2014. Carestream Health recommends that the DR 9000 U-arm be moved before positioning the patient under the U-arm for a decubitus exam. This will remove any potential safety hazard posed to the patient as a result of any unexpected movement. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the US, please call your local Service support number. |
| Quantity | Domestic: 100 units; Foreign: 46 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.