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U.S. Department of Health and Human Services

Class 2 Device Recall RelievRx

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 Class 2 Device Recall RelievRxsee related information
Date Initiated by FirmFebruary 27, 2023
Date PostedJune 30, 2023
Recall Status1 Completed
Recall NumberZ-2044-2023
Recall Event ID 92389
Product Classification Virtual reality behavioral therapy device for pain relief - Product Code QRA
ProductRelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
Code Information Serial Number: PA7940RGG5130514B; UDI: 0100850038247027211001077
FEI Number 3021071568
Recalling Firm/
Manufacturer		 Appliedvr
16760 Stagg St Ste 216
Van Nuys CA 91406-1642
Manufacturer 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.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionOn 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 Commerce1 unit
DistributionUS: NY OUS: None
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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