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Geri Embryo Incubator

GENEA BIOMEDX PTY LTD · Model GERI-INS-01 · UDI-DI 09348265003000

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter used to filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders. The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.

Recalls

Date	Firm	Reason
2022-04-01	CooperSurgical, Inc.	Products in this lot may have compromised barrier seals, introducing a risk to sterility.
2014-06-20	ORIGIO, Inc	Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
2011-11-28	ORIGIO HUMAGEN PIPETS INC.	Cryopettes were rupturing during the warming process following vitrification.
2007-05-08	Humagen Fertility Diagnostics, Inc.	Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

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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.