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MIRI Time-Lapse Incubator
ESCO MEDICAL TECHNOLOGIES UAB · Model MIRI TL12 · UDI-DI 04779041940311
PUB
Prescription
1
510(k) clearances
5
Adverse events
6
Recalls
21
Facilities
Description
Esco Medical MIRI® TL family`s multiroom IVF incubators are intended to provide an environment with controlled temperature, CO2 and other gases for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. The device use is limited up to six days (199 hours), covering the time from post-fertilization to day 6 of the development.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-15 | CooperSurgical, 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 |
| 2024-11-15 | CooperSurgical, 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 |
| 2024-11-15 | CooperSurgical, 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 |
| 2024-11-15 | CooperSurgical, 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 |
| 2024-11-15 | CooperSurgical, 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 |
| 2024-11-15 | CooperSurgical, 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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Get your free API keyRead the docsData 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.