Medical device recalls Moderate risk

Appliedvr recalls RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

Recall date
February 27, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2044-2023
FDA classification
Class II
Brand / firm
Appliedvr
Sold / distributed
US: NY OUS: None

Why it was recalled

There is the potential for the program software to malfunction which will not allow it to move forward to the next session.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

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