Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

On November 15, 2024 URGENT MEDICAL DEVICE RECALL emails were sent to customers. On November 20, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions that should be taken by the customer/user/distributor in order to prevent risks for patients or users: G85 Mini Incubators with serial numbers listed in the Appendix are impacted and require repair. 1. Inspect your inventory, identify, and discontinue use. 2. Complete the attached Urgent Medical Device Recall Response Form and return the form to CooperSurgical as indicated at the top of the form. Note: Please complete and return the form even if you do not have any affected product in your inventory so that we may document receipt of this Urgent Medical Device Recall. 3. Contact your local Service Representative to arrange a repair at no cost to you. T45, T47, R65, and G73 with serial numbers listed in the Appendix may be impacted and require inspection to determine the need for repair. 1. Inspect your inventory, identify, and discontinue use. 2. Complete the attached Urgent Medical Device Recall Response Form and return the form to CooperSurgical as indicated at the top of the form. Note: Please complete and return the form even if you do not have any affected product in your inventory so that we may document receipt of this Urgent Medical Device Recall. 3. Contact your local Service Representative to arrange an inspection of the affected product. If your product is affected, the product will be repaired at no cost to you. 6. Actions planned by CooperSurgical to correct the problem CooperSurgical is currently investigating this issue and determined a field action notice to customers is needed to inspect and repair all affected products in the field. CooperSurgical is committed to high-quality, safe, and effective products. This corrective action has been initiated to ensure this failure mode does not reoccur and future potential patient harm can be avoided. If you need any further