VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Reported: December 18, 2019 Initiated: November 16, 2018 #Z-0663-2020
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.
Details
- Recalling Firm
- LivaNova USA Inc
- Units Affected
- 643 units
- Distribution
- IL, AK, AL, AR, AZ, CA, CA , CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD MI, MN, MO, MS, MT, NC, ND, NE, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WA , WI, WV, WY,
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly. Recalled by LivaNova USA Inc. Units affected: 643 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0663-2020.
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