FDA recall Z-2044-2023

Product

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

Reason for recall

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

Distribution

US: NY OUS: None

Key facts

Status

Completed

Initiation date

2023-02-27

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Van Nuys, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2044-2023