Recall Z-2041-2020— Immersivetouch Inc
Class III · Ongoing
Class III FDA medical device recall by Immersivetouch Inc, initiated 2020-04-03. It names one FDA 510(k) clearance: K140860. Product: ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options. Reason: Observed an internal repetitive software glitch in ImmersiveView..
- Recalling firm
- Immersivetouch Inc
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2020-04-03
- Firm location
- Chicago, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.