Recall Z-1206-2023 ยท KPR System, X-Ray, Stationary
Carestream Health, Inc.
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standal
| Date | Mar 2, 2023 (initiated Jan 30, 2023) |
| Status | Open, Classified |
| Reason | After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury |
| Root cause | Software design |
| Action | Carestream issued Urgent Medical Device Correction Letter to Director of Radiology, Chief Radiology Administrator and DRX-Compass/DR-FIT X-ray System Administrators (US) consignees on 1/30/23. Letter states reason for recall, health risk and action to take: Do not use the Z-Axis Motorized button on the Tube Head Display at this time. Use the Brake Release buttons (Items 5 or 8) to manually move the OTC in the Z-Axis. " Press any E-stop button to stop unexpected movement immediately. " A Service Representative will install a Firmware correction. Action to be taken: A Carestream Service Engineer |
| Quantity | 72 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of California, Idaho, Illinois, Massachusetts, Minnesota, Nevada, North Carolina, Texas Wisconsin and the countries of Argentina, Australia, Brazil, China, Finland, France, INDIA, ITALY, Korea, Malaysia, Poland, Republic of Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201373 | DRX-Compass Carestream Health, Inc., Jun 26, 2020 |