Recall Z-0663-2020— LivaNova USA Inc
Class II · Ongoing
Class II FDA medical device recall by LivaNova USA Inc, initiated 2018-11-16. FDA's recall record names no specific 510(k) clearance for this event. Product: VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly. Reason: This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up..
- Recalling firm
- LivaNova USA Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-11-16
- Firm location
- Houston, TX, United States
Product description
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Reason for recall
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
Data sourced from openFDA. This site is unofficial and independent of the FDA.