Recall Z-2279-2023 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE OEC Medical Systems, Inc
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
| Date | Jul 31, 2023 (initiated May 15, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| 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 fieldactionssurgery@ge.c |
| Quantity | 16 |
| Distribution | 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, A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Mar 12, 2001 |
| K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Apr 17, 2002 |
| K073543 | OEC 9900 ELITE Ge Oec Medical Systems, May 2, 2008 |
| K111551 | OEC(R) 9800, OEC(R) 9800 PLUS Ge Oec Medical Systems, Inc., Oct 4, 2011 |
| K120613 | OEC 9900 ELITE Ge Healthcare Surgery GE Oec Medical Systems, Inc., Apr 6, 2012 |
| K132027 | OEC 9800 PLUS Ge Oec Medical Systems, Inc., May 1, 2014 |