RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
Summary
The FDA issued a Class II for RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for p by Appliedvr. Reason: There is the potential for the program software to malfunction which will not allow it to move forward to the next session..
Details
Source
Device Recall
External ID
Z-2044-2023
Action Date
2023-07-05
Status
Completed
Category
device
Product Description
RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
Lot/Code Info: Serial Number: PA7940RGG5130514B; UDI: 0100850038247027211001077
Quantity Affected: 1 unit
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.
Distribution
US: NY OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-27
Company
Van Nuys, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 367 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Appliedvr has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Appliedvr) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Appliedvr have FDA actions?
Appliedvr has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2044-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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