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ZEUS

AETHER BIOMEDICAL SP Z O O · Model Zeus V1 · UDI-DI 05904569152239

IQZ Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

ZeusV1 is designed for mild to moderate activities. Zeus v1 is an external prosthetic hand intended to be used with other appropriate upper limb components to form a complete arm prosthesis, to be fitted only by qualified and certified clinicians. It should be used only by upper limb (forearm). Zeus V1 is suitable for 3 amputation levels: below-elbow, above-elbow and shoulder. For right hand.

Recalls

Date	Firm	Reason
2024-08-22	Kinova Inc	Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.
2005-02-01	Motion Control, Inc.	Incorrect AC wall adapter was distributed with prostheses. Incorrect use of adapters could damage the battery and cause a potential fire hazard.

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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.