Virtual reality therapy device software malfunction prevents treatment progression
RelieVR VR behavioral therapy device software may malfunction, preventing progression to the next treatment session. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II medical device recall with reported software functionality defect. No illnesses or injuries have been reported, and the hazard is operational rather than presenting direct patient safety risk.
Plain-English summary
RelieVR (Model RVX-2002) is a prescription medical device manufactured by AppliedVR that delivers virtual reality-based behavioral therapy for pain relief.
The FDA has identified a potential software malfunction that may prevent the device from advancing to the next session during treatment. This malfunction could interrupt the therapeutic workflow and prevent patients from completing their treatment sessions.
The recalled device was distributed in New York. No illnesses or injuries have been reported to the FDA at this time.
Patients currently using RelieVR should contact their healthcare provider or AppliedVR if they experience software malfunctions or difficulty advancing between sessions. Healthcare providers should evaluate whether to discontinue use pending resolution of the software issue.
The recalled product
- Product
- RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
- Manufacturer
- Appliedvr
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Number: PA7940RGG5130514B
- UDI: 0100850038247027211001077
Distribution
Distributed in 1 state:
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