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Open, Classified

Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems

FDA Recall Z-2279-2023 · Posted 2023-07-31

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusOpen, Classified
Product CodeOXO
Date Initiated2023-05-15
Product Quantity16

Reason for Recall

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

Firm Action

On 5/15/23 correction notices were mailed to: Director/Manager of Radiology, Hospital Administrator, Head of Radiology Department, PACS Administrator, Director of IT Department, Head, Biomedical Engineering, who were asked to do the following: You can continue to use your device. When transporting the device, ensure it is always in the Anterior Posterior (AP) position, as instructed in the systems Operator Manual. Use caution when moving system to avoid a large impact force. In addition, customers were asked to complete and return the acknowledgement response form to [email protected] Customers with questions or concerns can contact the firm at 1-800-437-1171

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Czechia, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, France, Georgia, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, KOREA, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, New Caledonia, New Zealand, Nigeria, Paraguay, Peru, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120613OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012-04-06K111551OEC(R) 9800, OEC(R) 9800 PLUSGe Oec Medical Systems, Inc. · 2011-10-04K073543OEC 9900 ELITEGe Oec Medical Systems · 2008-05-02K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2002-04-17K003837FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2001-03-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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