EmbryoScope+

Vitrolife A/S · Model ES-P1 · UDI-DI 05712714604010

MQK MTX MQG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development. The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator. The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not control any hardware components in the EmbryoScope+ incubator. The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters. The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.

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.