Recall Z-2044-2023 ยท QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Appliedvr
RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
| Date | Jun 30, 2023 (initiated Feb 27, 2023) |
| Status | Completed |
| Reason | There is the potential for the program software to malfunction which will not allow it to move forward to the next session. |
| 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 | 1 unit |
| Distribution | US: NY OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.