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Multiroom IVF incubator

ESCO MEDICAL TECHNOLOGIES UAB · Model MIRI Humidity · UDI-DI 04779041940243

PUB Prescription
1
510(k) clearances
5
Adverse events
6
Recalls
21
Facilities

Description

The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a stable culture environment at or near body temperature and CO2/N2 or premixed gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF)/assisted reproduction technology (ART) treatments.

Recalls

DateFirmReason
2024-11-15CooperSurgical, Inc.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 al
2024-11-15CooperSurgical, Inc.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 al
2024-11-15CooperSurgical, Inc.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 al
2024-11-15CooperSurgical, Inc.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 al
2024-11-15CooperSurgical, Inc.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 al
2024-11-15CooperSurgical, Inc.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 al

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.