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Recall Observatory FDA recall evidence

Device product

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

Z-2044-2023

February 27, 2023

Class II

Product summary

Firm
Appliedvr
Event
Event 92389
Status
Completed
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2044-2023

Official wording

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

Code information: Serial Number: PA7940RGG5130514B; UDI: 0100850038247027211001077

Distribution pattern: US: NY OUS: None

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software to malfunction