ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.

Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

On 08/11/2026, an "URGENT: Medical Device Correction" letter was email or FedEx'd informing customer that, based on customer feedback, BD has identified that during manufacturing, the laterality identification labels may be missing or inaccurately placed on the device. There is potential that the labels on the green cables may have been switched, with the channel 1 cable labeled as channel 2, and the channel 2 cable labeled as channel 1. This will lead to a mismatch as to the left and right values displayed on the monitor and what the labels indicate on the cables. Customers are instructed to check devices in clinical use and in inventory: 1. Verify for the presence of the flag, sensor, and channel labels on the device. 2. Verify that the flag and sensor labels correspond to the correct channel label on the housing (See picture included in the customer notification for correct label placement). 3. If either of the labels are missing, or the flag label and/or the sensor label do not match the channel label on the housing, contact Technical Support for further assistance. If the flag and sensor labels correctly correspond to the channel labels, as seen in the pictures, there is no further action required. 4. Provide a copy of this notification to any customers and/or facilities you may have distributed devices to. 5. Post this notice on or segregate the impacted unit(s) until correction is completed. 6. Complete the attached Customer Response Form and return it to the BD contact noted on the form whether or not you have any of the impacted products so that BD may acknowledge your receipt of this notification. For questions for assistance: Recall Customer Response Forms - Fax: 1-312-949-0410; Email: [email protected] Technical/Product Complaints - Phone: 1.800.822.9837 Email: [email protected]