CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Des

Recalled December 25, 2024 · FDA recall Z-0689-2025 · CooperSurgical

Hazard

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. · FDA Class II

Units

22 units

Sold at

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 recall guidelines. Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZA

Description

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.

Product

Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 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: No

Manufacturer(s)

CooperSurgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →