CLASS II Device recall · Reported 5 Jul 2023 · FDA Enforcement Report
RelieVR REF: Rvx-2002, Rx Only. Virtual reality behavioral therapy recalled
Appliedvr is recalling RelieVR REF: Rvx-2002, Rx Only. Virtual reality behavioral therapy, distributed in New York. The recall was initiated on 27 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2044-2023
- FDA event ID
- 92389
- Recalling firm
- Appliedvr, Van Nuys, CA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 27 Feb 2023
- FDA classified
- 29 Jun 2023
- Reported
- 5 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Feb 2023 | Recall initiated by company | |
| 29 Jun 2023 | Classified by FDA | +122 days |
| 5 Jul 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
Where it was distributed
US: NY OUS: None
Questions about this recall
Is RelieVR REF: Rvx-2002, Rx Only. Virtual reality behavioral therapy recalled?
Yes. Appliedvr recalled RelieVR REF: Rvx-2002, Rx Only. Virtual reality behavioral therapy on 27 Feb 2023. The recall is Class II and its status is Completed. Recall number Z-2044-2023.
Why was it recalled?
There is the potential for the program software to malfunction which will not allow it to move forward to the next session.
Which lots are affected?
Serial Number: PA7940RGG5130514B; UDI: 0100850038247027211001077
Where was it sold?
US: NY OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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