Recall Z-2572-2018— LivaNova USA Inc
Class II · Terminated
Class II FDA medical device recall by LivaNova USA Inc, initiated 2018-01-24, terminated 2023-11-29. FDA's recall record names no specific 510(k) clearance for this event. Product: VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2. Reason: Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer..
- Recalling firm
- LivaNova USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-24
- Terminated
- 2023-11-29
- Firm location
- Houston, TX, United States
Product description
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Reason for recall
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.