Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Produc

FDA device recall Z-0692-2025 · posted 2024-12-18 · Open, Classified

Recall details

Recalling firm

CooperSurgical, Inc.

Reason for recall

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.

Action taken

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

Root cause

Process change control

Status

Open, Classified

Product code

PUB

Quantity affected

34 units

Distribution

States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or

Date initiated

2024-11-15

Date posted

2024-12-18

Location

Trumbull, CT