Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.
Recall
- Recall Number
- Z-1958-2019
- Event Number
- 83193
- Firm
- Canon Medical System, USA, INC.
- FEI Number
- 2020563
- Product Code
- MQB
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 16, 2018
- Terminated
- July 20, 2020
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047
Description
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.
software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no image available. It also showed the "OK" button to reacquire image data from the FPD, and the "Cancel" button to cancel the acquisition . When the user selects the "OK" button, the same message window appears. This prompted the user to repeat the same operation several times and finally select the "Cancel" button to quit the reacquistion mode.
On October 16, 2019, the firm sent an urgent medical device correction letter via USPS, return receipt to all customers who were distributed the affected device. The notification letter ask customers to do the following: 1. Should the problem occur before the modified software is installed on your system, please reduce the number of other devices which use the same wireless channel as this system as much as possible to avoid heavy wireless traffic. 2. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility 3. Please complete and return the customer reply form via email to [email protected] or by fax to regulatory affairs at 877-349-3054. 4. If you have any questions regarding the letter, please contact Terry Schultz, Regulatory Affairs Manager at (800) 421-1968 or contact your local Canon Representative at (800) 521-1968.
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