Recall record at a glance
| Official record | Z-1958-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Canon Medical System, USA, Inc. |
| Report date | Jul 17, 2019 |
| Recall initiation date | Oct 16, 2018 |
| Quantity | 46 |
| Location | Tustin, CA, United States |
Official product 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.
Why the product was recalled
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.
Distribution information
US Nationwide Distribution - PA, UT, FL, NY, AR, LA, WV, NJ, OH, MI, WI, TN, TX, VT, GA, NC, IL
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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