OEC Elite Systems with 9-inch Image Intensifier

FDA device recall Z-2278-2023 · posted 2023-07-31 · Open, Classified

Recall details

Recalling firm: GE OEC Medical Systems, Inc
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.
Action taken: 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.com Customers with questions or concerns can contact the firm at 1-800-437-1171
Root cause: Process control
Status: Open, Classified
Product code: OWB
Quantity affected: 812
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
Date initiated: 2023-05-15
Date posted: 2023-07-31
Location: Salt Lake City, UT

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