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Multiroom IVF incubator
ESCO MEDICAL TECHNOLOGIES UAB · Model MIRI M Chamber · UDI-DI 04779041940809
PUB
Prescription
1
510(k) clearances
5
Adverse events
6
Recalls
21
Facilities
Description
The Esco Medical MIRI® M multiroom IVF incubators are intended to be used by trained healthcare professionals in the in vitro fertilisation (IVF) / assisted reproduction technology (ART) facilities to maintain and provide a stable culture environment with controlled temperature and CO2/O2 gas concentration for fertilised oocytes to the blastocyst stage during IVF / ART treatments and optionally to capture time lapse images of these during incubation.
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.