Z-2044-2023Class II

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

Name: Z-2044-2023 RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief
Creator: Appliedvr
Published: 2023-02-27
License: https://open.fda.gov/license/

Appliedvr / initiated 2023-02-27 / Completed / root cause: software

FDA source

Appliedvr began a recall of RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief on 2023-02-27. FDA classified it as Class II and gives the reason as "There is the potential for the program software to malfunction which will not allow it to move forward to the next session". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-2044-2023
Classification: Class II
Status: Completed
Initiated: 2023-02-27
Posted: 2023-06-30
Recalling firm: Appliedvr
Product: RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
Product code: QRA 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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: On May, 2, 2023, AppliedVR provided customers with a Medical Device Recall notification in person. The recall notification informed the customer that the device was being recalled. For questions contact AppliedVR or your Health Care Provider.
Quantity in commerce: 1 unit
Distribution: US: NY OUS: None
Product codes and lots: Serial Number: PA7940RGG5130514B; UDI: 0100850038247027211001077

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2044-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2044-2023	Class II	Completed	Voluntary: Firm initiated	2023-07-05	2023-06-29

Product code QRA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)