Recall archive / FDA device enforcement
RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief. — FDA record Z-2044-2023
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 27, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
- Reason
- There is the potential for the program software to malfunction which will not allow it to move forward to the next session.
- Classification
- Class II
- Recalling firm
- Appliedvr
- Quantity
- 1 unit
- Agency-reported status
- Completed
- Source record identifier
- Z-2044-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial Number: PA7940RGG5130514B; UDI: 0100850038247027211001077 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: NY OUS: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 5, 2023
- Recall initiation date
- Feb 27, 2023
- Center classification date
- Jun 29, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.