Recall Z-1563-2020— LivaNova USA Inc
Class II · Ongoing
Class II FDA medical device recall by LivaNova USA Inc, initiated 2020-02-04. FDA's recall record names no specific 510(k) clearance for this event. Product: VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.. Reason: False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention..
- Recalling firm
- LivaNova USA Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-02-04
- Firm location
- Houston, TX, United States
Product description
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
Reason for recall
False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.
Data sourced from openFDA. This site is unofficial and independent of the FDA.