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Multi-zone ART Workstation

ESCO MEDICAL TECHNOLOGIES UAB · Model MAW-4D · UDI-DI 04779041940465

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

Description

The Multi-zone ART Workstation is a laminar flow workstation intended to work with gametes and/or embryos at or near body temperature during in vitro fertilization (IVF)/assisted reproduction technology (ART) procedures. The workstation also provides humidified gas to maintain gametes and embryos in the working environment.

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.