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Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Prod...

FDA Device Recall #Z-1958-2019 — Class II — October 16, 2018

Recall Summary

Recall Number Z-1958-2019
Classification Class II — Moderate risk
Date Initiated October 16, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Canon Medical System, USA, INC.
Location Tustin, CA
Product Type Devices
Quantity 46

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.

Reason for Recall

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 Pattern

US Nationwide Distribution - PA, UT, FL, NY, AR, LA, WV, NJ, OH, MI, WI, TN, TX, VT, GA, NC, IL

Lot / Code Information

No./Serial No./Manufacture Date: No 1./U8A1312001/JANUARY 2013; No.2/U8A1312002/JANUARY 2013; No.3/U8A1342003/APRIL 2013; No.4/U8A1362004 /JUNE 2013; No. 5 U8B13X2006/OCTOBER 2013; No. 6 U8B13Z2008/DECEMBER 2013; No. 7 U8B1412009/JANUARY 2014; No. 8 U8B1432010 /MARCH 2014; No. 9 U8B1442011/APRIL 2014; No.10 U8B1462013/JUNE 2014; No.11 U8B1472014/JULY 2014; No.12 U8B1482015/AUGUST 2014; No.13 U8B14Y2016/NOVEMBER 2014; No.14 U8B14Z2017/DECEMBER 2014; No.15 U8B14Z2018/DECEMBER 2014; No.16 U8B14Z2019/DECEMBER 2014; No.17 U8B1512020/JANUARY 2015; No.18 U8B1522021/FEBRUARY 2015; No.19 U8B1522022/FEBRUARY 2015; No.20 U8B1522023/FEBRUARY 2015; No.21 U8B1522024/FEBRUARY 2015; No.22 U8B1612025/JANUARY 2016; No.23 U8B1632026/MARCH 2016; No.24 U8B1642027/APRIL 2016; No.25 U8B1642028/APRIL 2016; No.26 U8B1642029/APRIL 2016; No.27 U8B1662030 /JUNE 2016; No.28 U8B1677001/JULY 2016; No.29 U8B16X2032/OCTOBER 2016; No.30 U8B1722033 /FEBRUARY 2017; No.31 U8B1752034/MAY 2017; No.32 U8B1762035/JUNE 2017; No.33 U8B1782036 /AUGUST 2017; No.34 U8B17Z2037 /DECEMBER 2017; No.35 U8C1812038/JANUARY 2018; No.36 USA1462001/JUNE 2014; No.37 USA1492002/SEPTEMBER 2014; No.38 USA14Z2003/DECEMBER 2014; No.39 USA1512004/JANUARY 2015; No.40 USA1532005/MARCH 2015; No.41 USA15Z2006/DECEMBER 2015; No.42 USA1662007/JUNE 2016; No.43 USA1682008/AUGUST 2016; No.44 USA16X2009/OCTOBER 2016; No.45 USA16Y2011/NOVEMBER 2016; No.46 U8A1372005/JULY 2013; No.47 U8B13X2007/OCTOBER 2013; No.48 USA16X2010/OCTOBER 2016

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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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