Z-2041-2020 Class III Ongoing
FDA device recall Z-2041-2020 was initiated by Immersivetouch Inc on April 3, 2020 and is designated Class III. Reason for recall: Observed an internal repetitive software glitch in ImmersiveView. The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 3, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Reason for Recall
Observed an internal repetitive software glitch in ImmersiveView.
Distribution Pattern
The device was distributed in the state of Illinois only.
Code Information
V 2.1