Z-2044-2023 Class II
FDA device recall Z-2044-2023 was initiated by Appliedvr on February 27, 2023 and is designated Class II. 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. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- February 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
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 Pattern
US: NY OUS: None
Code Information
Serial Number: PA7940RGG5130514B; UDI: 0100850038247027211001077