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 standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).
Recall
- Recall Number
- Z-1206-2023
- Event Number
- 91698
- Firm
- Carestream Health, Inc.
- FEI Number
- 1317307
- Product Code
- KPR
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- January 30, 2023
- Posted
- March 2, 2023
- Address
- 1049 W Ridge Rd, Rochester, NY, 14615-2731
Description
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 standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).
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
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 or Carestream Health Authorized Representative will contact your site and setup a service call to inspect your device and install a new firmware version. For your convenience, a Notification Acknowledgement form has been provided with this letter. Please read and complete the information within 5 working days. Remit the completed form by e-mail to: [email protected]. Questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Carestream S vice support number
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.
72 units